May 2015 - PerformRx

May 2015*
Drug Information Update
*Includes drug information from April-May 2015
DRUG INFORMATION UPDATE
Table of Contents
NEW GENERICS TO MARKET ........................................................................................................... 2
NEW DRUG ENTITIES....................................................................................................................... 3
NEW INDICATIONS (EXISTING DRUGS) ........................................................................................... 5
FDA NEWS/BULLETINS/ADVISORIES/SAFETY ALERTS ..................................................................... 6
STUDIES and RECENT TOPICS ........................................................................................................ 11
RECALLS ......................................................................................................................................... 15
CURRENT DRUG SHORTAGES ...................................................................................................... 208
NEW DRUGS COMING TO MARKET ............................................................................................ 248
Copyright© PerformRx, LLC 2015 All Rights Reserved
1
NEW GENERICS TO MARKET
GENERIC DRUG NAME
PRAMIPEXOLE DI-HCL
STRENGTH &
DOSAGE FORM
0.375 MG/ TAB ER
24 H
GENERIC
MANUFACTURER
BRAND NAME
APPROVAL
DATE
PAR PHARM
MIRAPEX ER
04/22/2015
DURACHOL
04/22/2015
SUPRAX
05/01/2015,
04/23/2015
VITAMIN D3/FOLIC ACID
3775 U CAPSULE
CEFIXIME
100 MG/5ML,
RECON SUSP
ADLER-STERN
PHA
AUROBINDO
PHARM, LUPIN
BENZONATATE
150 MG, CAPSULE
ASCENCD
ZONATUSS
04/28/2015
ARIPIPRAZOLE
10 MG, TABLET
VARIOUS
ABILIFY
04/29/2015
ARIPIPRAZOLE
20 MG, TABLET
VARIOUS
ABILIFY
04/29/2015
ARIPIPRAZOLE
30 MG, TABLET
VARIOUS
ABILIFY
04/29/2015
ARIPIPRAZOLE
5 MG, TABLET
VARIOUS
ABILIFY
04/29/2015
ARIPIPRAZOLE
2 MG, TABLET
VARIOUS
ABILIFY
04/29/2015
BIMATOPROST
0.03%, DROPS
LUPIN
LUMIGAN
04/30/2015
15-90.314 CAPSULE
METHOD
PHARMACE.
LMETHYLFOLATE
FORTE
05/04/2015
TEVA
FAZACLO
TEVA
FAZACLO
LEVOMEFOLATE/ALGAL OIL
CLOZAPINE
CLOZAPINE
200 MG RAP DIS
TAB
150 MG RAP DIS
TAB
Copyright© PerformRx, LLC 2015 All Rights Reserved
05/04/201505/05/2015
05/04/201505/05/2015
2
NEW DRUG ENTITIES
DESCRIPTION
ANTIANGINAL, HEART
RATE REDUCING, I(F)
INHIBITOR
ANTIANGINAL, HEART
RATE REDUCING, I(F)
INHIBITOR
PRENATAL VITAMIN
PREPARATIONS
THROMBIN
INHIBITORS,SELECTIVE
,DIRECT, &
REVERSIBLE
ANTIOXIDANT
MULTIVITAMIN
COMBINATIONS
SEDATIVEHYPNOTICS,NONBARBITURATE
TX FOR ATTENTION
DEFICITHYPERACT(ADHD)/NA
RCOLEPSY
TX FOR ATTENTION
DEFICITHYPERACT(ADHD)/NA
RCOLEPSY
TX FOR ATTENTION
DEFICITHYPERACT(ADHD)/NA
RCOLEPSY
TX FOR ATTENTION
DEFICITHYPERACT(ADHD)/NA
RCOLEPSY
TX FOR ATTENTION
DEFICITHYPERACT(ADHD)/NA
RCOLEPSY
BRAND
NAME
CORLANOR
GENERIC NAME
STRENGTH
IVABRADINE HCL
5 MG
NOTES
NEW ENTITY
CORLANOR
IVABRADINE HCL
7.5 MG
NEW ENTITY
PROVIDA
DHA
PNV NO.90/IRON FUM &
PS/FA/DHA
32-1.25
MG
NEW
COMBINATION
ARGATROBA
N-0.9% NACL
ARGATROBAN IN 0.9 %
SOD CHLOR
250MG/25
0
NEW DOSAGE
FORM
MACUZIN
FA/VIT
C/E/ZINC/COPPER/LUT/Z
EA
MIDAZOLAM HCL
1-500-400
NEW ENTITY
5
MG/2.5ML
NEW
COMBINATION
APTENSIO XR
METHYLPHENIDATE HCL
10 MG
APTENSIO XR
METHYLPHENIDATE HCL
15 MG
NEW
STRENGTH
AND DOSAGE
FORM
DOSAGE FORM
APTENSIO XR
METHYLPHENIDATE HCL
20 MG
DOSAGE FORM
APTENSIO XR
METHYLPHENIDATE HCL
30 MG
DOSAGE FORM
APTENSIO XR
METHYLPHENIDATE HCL
40 MG
DOSAGE FORM
MIDAZOLAM
HCL
Copyright© PerformRx, LLC 2015 All Rights Reserved
3
DESCRIPTION
TX FOR ATTENTION
DEFICITHYPERACT(ADHD)/NA
RCOLEPSY
TX FOR ATTENTION
DEFICITHYPERACT(ADHD)/NA
RCOLEPSY
ANTIPSYCHOTICS,ATY
PICAL,DOPAMINE,&
SEROTONIN ANTAG
SSRI & 5HT1A PARTIAL
AGONIST
ANTIDEPRESSANT
LEUKOCYTE (WBC)
STIMULANTS
LEUKOCYTE (WBC)
STIMULANTS
NSAIDS,
CYCLOOXYGENASE
INHIBITOR - TYPE
NSAIDS,
CYCLOOXYGENASE
INHIBITOR - TYPE
BRAND
NAME
APTENSIO XR
GENERIC NAME
STRENGTH
NOTES
METHYLPHENIDATE HCL
50 MG
DOSAGE FORM
APTENSIO XR
METHYLPHENIDATE HCL
60 MG
DOSAGE FORM
SAPHRIS
ASENAPINE MALEATE
2.5 MG
NEW
STRENGTH
VIIBRYD
VILAZODONE
HYDROCHLORIDE
10 MG20MG
ZARXIO
FILGRASTIM-SNDZ
ZARXIO
FILGRASTIM-SNDZ
TIVORBEX
INDOMETHACIN,
SUBMICRONIZED
TIVORBEX
INDOMETHACIN,
SUBMICRONIZED
Copyright© PerformRx, LLC 2015 All Rights Reserved
NEW
DOSEPACK
STRENGTH
480MCG/0. NEW
8
BIOSIMLIAR
300MCG/0. NEW
5
BIOSIMLIAR
20 MG
NEW
STRENGTH
40 MG
NEW
STRENGTH
4
NEW INDICATIONS (EXISTING DRUGS)
DRUG
NEW INDICATION
DATE OF APPROVAL
LINKS
MINOCIN®
New formulation for
injection
04/20/2015
AGGRASTAT®
Revision of bolus
04/23/2015
delivery high-dose
bolus regimen; allows
the delivery duration
of aggrastate high
dose bolus 25mcg/kg
to occur anytime
within 5 minutes
For use with folfiri in
04/24/2015
second-line treatment
of metastatic
colorectal cancer
Minocin® [package
insert]. The Medicines
Company April 2015.
Aggrastat® [package
insert]. Medicure
April 2015.
CYRAMZA®
BREO® ELLIPTA®
Once daily treatment
of asthma in patients
aged 18 years and
older
Copyright© PerformRx, LLC 2015 All Rights Reserved
04/30/2015
Cyramza® [package
insert]. Eli Lilly and
Company April 2015.
Breo®Ellipta®
[package insert].
GlaxoSmithKline April
2015.
5
FDA NEWS/BULLETINS/ADVISORIES/SAFETY ALERTS
Injectable Products by Mylan: Recall - Presence of Particulate Matter
[Posted 04/24/2015]
ISSUE: Mylan N.V. is conducting a voluntary nationwide recall to the hospital/user level of
select lots of injectable products due to the presence of visible foreign particulate matter
observed during testing of retention samples.
Administration of a sterile injectable that has foreign particulates has the potential of severe
health consequences. Intrathecal administration could result in a life threatening adverse event
or result in permanent impairment of a body function. Intravenous administration has the
potential to damage and/or obstruct blood vessels which could induce emboli, particularly in
the lungs. If a right to left cardiac shunt is present, the particulate may lead to arterial emboli
and result in stroke, myocardial infarction, respiratory failure, and loss of renal and hepatic
function or tissue necrosis. Other adverse effects associated with intravenous injection of
particulate matter include local inflammation, phlebitis, allergic response and/or embolization
in the body and infection. Intra-arterial administration could result in damage to blood vessels
in the distal extremities or organs. Intramuscular administration could result in foreign-body
inflammatory response, with local pain, swelling and possible long term granuloma formation.
BACKGROUND: Gemcitabine for Injection, USP 200mg is an intravenously administered product
indicated for the treatment of ovarian cancer, breast cancer, non-small cell lung cancer and
pancreatic cancer. These lots were distributed in the U.S. between Feb. 18, 2014, and Dec. 19,
2014, and were manufactured and packaged by Agila Onco Therapies Limited, a Mylan
company. Lot 7801089 is packaged with a Pfizer Injectable label.
Carboplatin Injection 10mg/mL is an intravenously administered product indicated for the
treatment of advanced ovarian carcinoma. The lot was distributed in the U.S. between Aug. 11,
2014, and Oct. 7, 2014, and was packaged by Agila Onco Therapies Limited, a Mylan company,
with a Mylan Institutional label.
Methotrexate Injection, USP 25mg/mL can be administered intramuscularly, intravenously,
intra-arterially, or intrathecally and is indicated for certain neoplastic diseases, severe psoriasis
and adult rheumatoid arthritis. The lot was distributed in the U.S. between Jan. 16, 2014, and
March 25, 2014, and was packaged by Agila Onco Therapies Limited, a Mylan company, with a
Pfizer Injectables label.
Cytarabine Injection can be administered intravenously or intrathecally and in combination with
other approved anti-cancer drugs is indicated for remission induction in acute non-lymphocytic
leukemia of adults and pediatric patients. The lot was distributed in the U.S. between May 02,
2014, and July 24, 2014, and was manufactured and packaged by Agila Onco Therapies Limited,
a Mylan company located in Bangalore, India and is packaged with a Pfizer Injectables label.
Copyright© PerformRx, LLC 2015 All Rights Reserved
6
RECOMMENDATION: Mylan is notifying its distributors and customers by letter and is arranging
for return of all recalled products. Distributors, retailers, hospitals, clinics, and physicians that
have these products which are being recalled should stop use and return to place of purchase.
Consumers with questions regarding this recall can contact Mylan Customer Relations at
800.796.9526 or customer.service@mylan.com, Monday through Friday from 8 a.m. - 5 p.m.
EST.
Consumers should contact their physician or healthcare provider if they have experienced any
problems that may be related to using these drug products.
Healthcare professionals and patients are encouraged to report adverse events or side effects
related to the use of these products to the FDA's MedWatch Safety Information and Adverse
Event Reporting Program:


Complete and submit the report Online: www.fda.gov/MedWatch/report
Download form or call 1-800-332-1088 to request a reporting form, then complete and
return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
SOURCE: U.S. Food and Drug Administration (FDA)
ARTICLE LINK:
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProdu
cts/ucm444517.htm
Adrucil (fluorouracil Injection, USP) 5 g/100 mL (50 mg/mL): Recall - Particulate Matter
[Posted 05/05/2015]
ISSUE: Teva Parenteral Medicines issued a voluntary recall of eight lots of Adrucil (fluorouracil
injection, USP) 5 g/100 mL (50 mg/mL) due to the potential presence of particulate matter
identified as aggregate of silicone rubber pieces from a filler diaphragm and fluorouracil
crystals. See the press release for a listing of affected lot numbers.
Administration of an intravenous product with particulate matter has the potential to result in
inflammation, allergic reactions, or blockage of blood vessels, leading to tissue death, which
may be life-threatening if vital organs are affected.
BACKGROUND: Adrucil Injection is used in the palliative management of carcinoma of the
colon, rectum, breast, stomach and pancreas and is packaged in pharmacy bulk packages. The
pharmacy bulk package has five 5 g/100ml vials per shelf pack. Individual Adrucil 5 g/100 ml
vials have the NDC code 0703-3019-11 and the pharmacy shelf pack has the NDC code 07033019-12. The Adrucil 5 g/100 ml vial can be further identified by the statement on the label in
red that states "PHARMACY BULK PACKAGE NOT FOR DIRECT INFUSION". Adrucil 5 g/100 ml
Copyright© PerformRx, LLC 2015 All Rights Reserved
7
vials were distributed in the United States. Teva has distributed this product through the
normal distribution chain of wholesalers, retailers, and pharmacies.
RECOMMENDATION: Anyone with an existing inventory of the recalled lots should stop use and
distribution, and quarantine the product immediately. Customers should notify all users in their
facility. Customers who have further distributed the recalled product should notify any
accounts or additional locations which may have received the recalled product and instruct
them if they have redistributed the product to notify their accounts, locations or facilities to the
user level.
Consumers should contact their physician or healthcare provider if they have experienced any
problems that may be related to taking this drug product.
Teva has notified its direct customers by mail and has issued an Urgent Drug Recall Letter to
direct customers. Teva is arranging for impacted product to be returned to Inmar.
Healthcare professionals and patients are encouraged to report adverse events or side effects
related to the use of these products to the FDA's MedWatch Safety Information and Adverse
Event Reporting Program:


Complete and submit the report Online: www.fda.gov/MedWatch/report
Download form or call 1-800-332-1088 to request a reporting form, then complete and
return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
SOURCE: U.S. Food and Drug Administration (FDA)
ARTICLE LINK:
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProdu
cts/ucm445606.htm
SGLT2 inhibitors: Drug Safety Communication - FDA Warns Medicines May Result in a Serious
Condition of Too Much Acid in the Blood
[Posted 05/15/2015]
ISSUE: FDA is warning that the type 2 diabetes medicines canagliflozin, dapagliflozin, and
empagliflozin may lead to ketoacidosis, a serious condition where the body produces high levels
of blood acids called ketones that may require hospitalization. FDA is continuing to investigate
this safety issue and will determine whether changes are needed in the prescribing information
for this class of drugs, called sodium-glucose cotransporter-2 (SGLT2) inhibitors.
BACKGROUND: SGLT2 inhibitors are a class of prescription medicines that are FDA-approved
for use with diet and exercise to lower blood sugar in adults with type 2 diabetes. When
untreated, type 2 diabetes can lead to serious problems, including blindness, nerve and kidney
Copyright© PerformRx, LLC 2015 All Rights Reserved
8
damage, and heart disease. SGLT2 inhibitors lower blood sugar by causing the kidneys to
remove sugar from the body through the urine.
These medicines are available as single-ingredient products and also in combination with other
diabetes medicines such as metformin.
RECOMMENDATION: Patients should pay close attention for any signs of ketoacidosis and seek
medical attention immediately if they experience symptoms such as difficulty breathing,
nausea, vomiting, abdominal pain, confusion, and unusual fatigue or sleepiness. Do not stop or
change your diabetes medicines without first talking to your prescriber.
Health care professionals should evaluate for the presence of acidosis, including ketoacidosis, in
patients experiencing these signs or symptoms; discontinue SGLT2 inhibitors if acidosis is
confirmed; and take appropriate measures to correct the acidosis and monitor sugar levels. See
the FDA Drug Safety Communication for more information.
Healthcare professionals and patients are encouraged to report adverse events or side effects
related to the use of these products to the FDA's MedWatch Safety Information and Adverse
Event Reporting Program:


Complete and submit the report Online: www.fda.gov/MedWatch/report.htm
Download form or call 1-800-332-1088 to request a reporting form, then complete and
return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
SOURCE: U.S. Food and Drug Administration (FDA)
ARTICLE LINK:
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProdu
cts/ucm446994.htm
Testosterone Products: Drug Safety Communication - FDA Cautions About Using Testosterone
Products for Low Testosterone Due to Aging; Requires Labeling Change to Inform of Possible
Increased Risk of Heart Attack And Stroke
UPDATE 04/15/2015
[Posted 03/03/2015]
ISSUE: FDA is requiring that the manufacturers of all approved prescription testosterone
products change their labeling to clarify the approved uses of these medications. FDA is also
requiring these manufacturers to add information to the labeling about a possible increased
risk of heart attacks and strokes in patients taking testosterone. FDA cautions that prescription
testosterone products are approved only for men who have low testosterone levels caused by
certain medical conditions. The benefit and safety of these medications have not been
Copyright© PerformRx, LLC 2015 All Rights Reserved
9
established for the treatment of low testosterone levels due to aging, even if a man’s
symptoms seem related to low testosterone.
Based on the available evidence from studies and expert input from an FDA Advisory
Committee meeting, FDA has concluded that there is a possible increased cardiovascular risk
associated with testosterone use. These studies included aging men treated with testosterone.
Some studies reported an increased risk of heart attack, stroke, or death associated with
testosterone treatment, while others did not. See the Data Summary section of the FDA Drug
Safety Communication for additional details.
BACKGROUND: Testosterone is FDA-approved as replacement therapy only for men who have
low testosterone levels due to disorders of the testicles, pituitary gland, orbrain that cause
hypogonadism. However, FDA has become aware that testosterone is being used extensively in
attempts to relieve symptoms in men who have low testosterone for no apparent reason other
than aging. The benefits and safety of this use have not been established.
RECOMMENDATION: Health care professionals should prescribe testosterone therapy only for
men with low testosterone levels caused by certain medical conditions and confirmed by
laboratory tests. Health care professionals should make patients aware of the possible
increased cardiovascular risk when deciding whether to start or continue a patient on
testosterone therapy. Patients using testosterone should seek medical attention immediately if
symptoms of a heart attack or stroke are present, such as chest pain, shortness of breath or
trouble breathing, weakness in one part or one side of the body, or slurred speech.
Healthcare professionals and patients are encouraged to report adverse events or side effects
related to the use of these products to the FDA's MedWatch Safety Information and Adverse
Event Reporting Program:


Complete and submit the report Online: www.fda.gov/MedWatch/report
Download form or call 1-800-332-1088 to request a reporting form, then complete and
return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
SOURCE: U.S. Food and Drug Administration (FDA)
ARTICLE LINK:
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProdu
cts/ucm436280.htm
Copyright© PerformRx, LLC 2015 All Rights Reserved
10
STUDIES and RECENT TOPICS
Antibiotic Shortages On the Rise in U.S.
April 23, 2015
Commonly used medicines are essential, but not profitable for companies, expert says
Shortages of antibiotics, including those used to treat drug-resistant infections, may be putting
patients at risk for sickness and death, according to a new report.
Article link:
http://consumer.healthday.com/infectious-disease-information-21/antibiotics-news30/antibiotic-shortages-on-the-rise-in-u-s-698691.html?lexp=true&utm_expid=383530634.pIV1hUrQR8K_MJ1_OqjLag.1
Source: healthday.com
CDC: Time for all EMS staff to employ overdose-reversal drug
April 24, 2015
The Centers for Disease Control and Prevention on Friday urged emergency response
agencies to make sure all of their staff members know how to use an overdose-reversal
treatment that can prevent deaths from prescription opioid or heroin use.
Article link:
http://www.washingtontimes.com/news/2015/apr/24/cdc-time-ems-staff-employ-overdosereversal-drug/
Source: washingtontimes.com
Daily Aspirin Taken by More Than Half of Older U.S. Adults
April 24, 2015
Usage doesn't always comply with national guidelines
Slightly more than half of middle-aged adults and seniors in the United States take aspirin
daily to prevent heart attack, stroke or other serious illnesses, a new survey has found.
Article link:
http://consumer.healthday.com/general-health-information-16/aspirin-news-46/daily-aspirintaken-by-more-than-half-of-older-u-s-adults-698742.html?lexp=true&utm_expid=383530634.pIV1hUrQR8K_MJ1_OqjLag.1
Source: healthday.com
Copyright© PerformRx, LLC 2015 All Rights Reserved
11
Prescription Pain Pill Overuse Is Leading To Thousands Of Hospitalized Newborns
4/26/2015
The epidemic of overuse of prescription narcotic pills may be landing as many as 15,000
newborns in the intensive care unit at an annual cost of hundreds of millions of dollars to
the healthcare system, according to a new study published in the New England Journal of
Medicine.
Article link:
http://www.forbes.com/sites/matthewherper/2015/04/26/the-pain-pill-epidemic-is-hurtingnewborn-babies/
Source: forbes.com
Opioid Overdoses Decrease After Abuse-Deterrent Painkillers Enter Market,
Propoxyphene Exits
April 27, 2015
Curbing opioid overdoses in the United States has not only been the goal of many in the
medical community, it has also been an initiative of President Barack Obama’s. A couple of
recent changes in the painkiller market, however, may have contributed to a significant
decrease in both opioid dispensing and overdoses.
Article link:
http://www.forbes.com/sites/cjarlotta/2015/04/27/opioid-overdoses-decrease-after-abusedeterrent-opioids-enter-market-propoxyphene-exits/
Source: forbes.com
FDA aims to dispel 'myth of the medication-free pregnancy'
April 27, 2015
When Laura Wylie became pregnant for the second time, she confronted a vexing dilemma:
Stay on the antidepressants that could have adverse effects on her developing baby or risk
descending into a deep, black hole that left her feeling numb.
Article link:
http://www.chicagotribune.com/lifestyles/health/ct-prescription-drugs-pregnancy-met20150427-story.html#page=1
Source: chicagotribune.com
Copyright© PerformRx, LLC 2015 All Rights Reserved
12
ER Practices Key to Helping Those Addicted to Painkillers: Study
April 28, 2015
Giving patients a drug that helps ease withdrawal works better than simple referrals, experts
say. A comparison of three treatments for narcotic painkiller addiction found that patients
given the medication buprenorphine in the emergency department do better than those given
only referrals.
Article link:
http://consumer.healthday.com/mental-health-information-25/addiction-news-6/er-practiceskey-to-helping-those-addicted-to-painkillers-study698802.html?lexp=true&utm_expid=38353063-4.pIV1hUrQR8K_MJ1_OqjLag.1
Source: healthday.com
Study Casts Doubt on Use of Common Antibiotic for UTIs in Women
April 30, 2015
Canadian researchers find other antibiotics may beat nitrofurantoin, but one expert says
drug still usefulThe antibiotic most commonly prescribed for bladder and other urinary tract
infections,nitrofurantoin, may not be the most effective option, new research suggests.
More than 25 percent of older adults have reduced kidney function, and bladder infections
are a common complaint.
Article link:
http://consumer.healthday.com/infectious-disease-information-21/misc-infections-news411/study-casts-doubt-on-use-of-common-antibiotic-for-utis-in-women698883.html?lexp=true&utm_expid=38353063-4.pIV1hUrQR8K_MJ1_OqjLag.1
Source: healthday.com
A gram of prevention: Providers urged to go metric to avoid medication errors
May 1, 2015
Miscalculated drug dosages because of confusion when patients' weights are converted from
pounds to kilograms are common and can result in patients' receiving potentially fatal
overdoses. These errors persist despite years of adverse incidents, warnings and
recommended fixes, patient-safety experts say.
Article link:
http://www.modernhealthcare.com/article/20150501/NEWS/150509993/a-gram-ofprevention-providers-urged-to-go-metric-to-avoid
Source: modernhealthcare.com
Copyright© PerformRx, LLC 2015 All Rights Reserved
13
Lynparza, First In A New Class Of Cancer Drugs, Is Surprisingly Active In A Wide
Range Of Tumors
May 04, 2015
At the recent American Association of Cancer Research (AACR) meeting, one of the most
encouraging sets of presentations pertained to PARP inhibitors. What’s emerging is that this
new class of drugs, once considered of limited benefit and primarily for cancer patients with
BRCA mutations, offers a wide range of anti-tumor activity.
Article link:
http://www.forbes.com/sites/elaineschattner/2015/05/04/parp-inhibitors-a-new-class-ofcancer-drugs-show-surprisingly-wide-activity-in-early-trials/
Source: forbes.com
200-Year-Old Heart Drug Linked To Increased Risk Of Death
May 05, 2015
For more than 200 years physicians have been trying to figure out how and when to use the
heart drug digoxin. Although it has a narrow therapeutic window and potentially dangerous
interactions with other drugs, it is endorsed by current guidelines and widely given to
patients with heart failure (HF) and atrial fibrillation (AF). However, there have been no
randomized trials in AF and only one trial, the famous DIG trial, in HF. In that trial digoxin
had no impact on mortality but was found to help reduce the rate of hospitalization for HF.
Article link:
http://www.forbes.com/sites/larryhusten/2015/05/05/200-year-old-heart-drug-linked-toincreased-risk-of-death/
Source: forbes.com
FDA Approves 5 New Diet Drugs With Serious Side Effects
May 06, 2015
After $60 million spent on lobbying, the U.S Food and Drug Administration -- which had a
13-year history of rejecting new diet drugs -- has approved five new diet products with
potentially serious side effects, including suicidal thoughts and increased cancer risk.
Article link:
http://www.huffingtonpost.com/2015/05/06/fda-diet-drugs_n_7214948.html
Source: huffingtonpost.com
Copyright© PerformRx, LLC 2015 All Rights Reserved
14
RECALLS*
Product
Type
Drugs
Product
Description
CLASS I
0.9% Sodium
Chloride
Injection, USP,
250 mL, Rx Only
Code info.
Class
Reason for Recall
Recalling firm
Lot #: 44-002JT (the lot
number may
be followed by
01 to 99), Exp
08/01/2016
UPC CODE:
633090804649
Exp unknown
Class I
Presence of Particulate
Matter; Hospira has
identified the particulate
as a human hair, sealed
in the bag at the additive
port area.
Marketed Without an
Approved NDA/ANDA:
FDA analysis found
product to contain
sibutramine and
phenolphthalein
Marketed Without an
Approved NDA/ANDA:
FDA analysis found
product to contain
sibutramine and
phenolphthalein
Marketed without an
approved NDA/ANDA These products are being
recalled due to the
presence of synthetic
hormone/prohormone
(methylated anabolic
steroid) ingredient
making them
unapproved new drugs.
Marketed without an
approved NDA/ANDA These products are being
recalled due to the
presence of synthetic
hormone/prohormone
(methylated anabolic
steroid) ingredient
making them
Hospira Inc.
Drugs
Forever Beautiful
INFINITY,
capsules, 300mg
in 60-count
bottles
Class I
Drugs
Forever Beautiful
BEE POLLEN,
capsules, 250mg
in 60-count
bottles
UPC CODE:
633090804632
, Exp unknown
Class I
Drugs
M1-ALPHA LABS
MEGA MASS
BUILDER (M1A,
Methyl-1Etiocholenolol20mg,
Epietiocholanolo
ne) Capsules, 60
count bottle
All lots
Class I
Drugs
M14-MENT
ADVANCED MASS
BUILDER (7aMethyl-estra-4en-3,17-dione
MENT 5mg,
M14D 20 mg),
Capsules, 90
count bottle
All lots
Class I
Copyright© PerformRx, LLC 2015 All Rights Reserved
REFA
Enterprises,
LLC
REFA
Enterprises,
LLC
Anabolic
Science Labs,
LLC
Anabolic
Science Labs,
LLC
15
Product
Type
Product
Description
Code info.
Class
Drugs
HALO-70 MEGA
All lots
MASS BUILDER
(4-chloro-17amethyl-androst1,4-diene-3b,17bdiol 35mg),
Capsules, 60
count bottle
Class I
Drugs
7-MENT ALPHA
ADVANCED MASS
BUILDER (7amethyl-estra-4en-3,17-dione 10
mg), Capsules, 90
count bottle
All lots
Class I
Drugs
ESTRASTAIN PRO- All lots
ANABOLIC MASS
AND HARDENING
COMPLEX (Estra4,9,11-triene3,17-dione 15mg,
2a-3a-epithio17a-methyl-5aandrostan-17b-ol
10 mg), Capsules,
60 count bottle
SWOLL-250
All lots
SUPER MASS
BUILDER QUAD
STACK (18Methylestr-4-en3-one-17b-ol
15mg, 6-aChloro-androst-4en-17b-ol-3-one
Class I
Drugs
Class I
Copyright© PerformRx, LLC 2015 All Rights Reserved
Reason for Recall
unapproved new drugs.
Marketed without an
approved NDA/ANDA These products are being
recalled due to the
presence of synthetic
hormone/prohormone
(methylated anabolic
steroid) ingredient
making them
unapproved new drugs.
Marketed without an
approved NDA/ANDA These products are being
recalled due to the
presence of synthetic
hormone/prohormone
(methylated anabolic
steroid) ingredient
making them
unapproved new drugs.
Marketed without an
approved NDA/ANDA These products are being
recalled due to the
presence of synthetic
hormone/prohormone
(methylated anabolic
steroid) ingredient
making them
unapproved new drugs.
Marketed without an
approved NDA/ANDA These products are being
recalled due to the
presence of synthetic
hormone/prohormone
(methylated anabolic
steroid) ingredient
making them
Recalling firm
Anabolic
Science Labs,
LLC
Anabolic
Science Labs,
LLC
Anabolic
Science Labs,
LLC
Anabolic
Science Labs,
LLC
16
Product
Type
Product
Code info.
Description
15mg, 13-ethyl-3methoxy-gona2,5(10)-diene-17one 15mg, 2,17adimethyl-5aandrosta-1-en17b-ol-3-one 3
mg), Capsules, 90
count bottle
PROFESSIONAL
All lots
FORMEXX BLACK
(AromaMaXX
250mg: 13dimethyl1,2,7,8,9,11,12,14
,15,16decahydrocyclopenta[a]phe
nanthrene3,6,17-trione,4Androsten 4,17beta-diol-3one),
Capsules, 60
count bottle
EDGE Amplified
Lots: ALL
Weight Release
capsules, 400 mg,
60-count bottle.
Class
Drugs
iNDiGO capsules,
220 mg, 60-count
bottle
Lot: 000034,
Exp 04/10/17
Class I
Drugs
AMPD GOLD Bee
Pollen capsules,
350 mg, 60-count
Lots: ALL
Class I
Drugs
Drugs
Reason for Recall
Recalling firm
unapproved new drugs.
Class I
Marketed without an
approved NDA/ANDA These products are being
recalled due to the
presence of synthetic
hormone/prohormone
(methylated anabolic
steroid) ingredient
making them
unapproved new drugs.
Anabolic
Science Labs,
LLC
Class I
Marketed Without An
Approved NDA/ANDA:
Product was found to
contain undeclared
phenolphthalein and
fluoxetine, making EDGE
an unapproved drug.
Marketed Without An
Approved NDA/ANDA:
Product was found to
contain undeclared
phenolphthalein, making
iNDiGO an unapproved
drug.
Marketed Without An
Approved NDA/ANDA:
Product was found to
Detox
Transforms
Copyright© PerformRx, LLC 2015 All Rights Reserved
Detox
Transforms
Detox
Transforms
17
Product
Type
Product
Description
bottle
Code info.
Drugs
BtRiM Max
capsules, 60count bottle
Lot: 00002,
Exp 04/27/17
Class I
Drugs
iNSANE Bee
Pollen capsules,
200 mg, 60-count
bottle
Lot: 0000:02,
Exp 06/20/17
Class I
Drugs
ULTRA ZX
DIETARY
SUPPLEMENT
(Extracto de
Naranjo Amargo
70, Extracto de
semilla de Sen
47.6, Lagrima de
Coix 42, Almidon
Medico 84), 30
capsule bottles,
Epel 18 mg
Estradiol Pellet,
For In Office Use
Only, For In Office
Administration
Only, Not for
Resale or
Dispensing to an
Individual
Patient, Rx Only.
0.9% Sodium
All
lots/codes/bot
tles/packages.
Class I
Lot #
06241401070714Q, Exp
12/14
Class I
Non-Sterility: The
Physician
recalled lot failed sterility Preferred
testing.
Medical, LLC
Lot # 45-110-
Class I
Presence of Particulate
Drugs
Drugs
Class
Copyright© PerformRx, LLC 2015 All Rights Reserved
Reason for Recall
contain undeclared
sildenafil, making AMPD
GOLD an unapproved
drug.
Marketed Without An
Approved NDA/ANDA:
Product was found to
contain undeclared
phenolphthalein, making
BtRiM Max an
unapproved drug.
Marketed Without An
Approved NDA/ANDA:
Product was found to
contain undeclared
phenolphthalein and
fluoxetine, making
iNSANE an unapproved
drug.
Marketed Without An
Approved NDA/ANDA:
FDA laboratory analysis
confirmed that ULTRA ZX
contains undeclared
sibutramine and
phenolphthalein
Recalling firm
Detox
Transforms
Detox
Transforms
Ultra ZX
Supplements
Hospira Inc.
18
Product
Type
Drugs
Drugs
Drugs
Product
Description
Chloride
Injection, USP,
250 mL, Rx only,
VisIV Container
MAGNESIUM
SULFATE IN 5%
DEXTROSE
INJECTION, USP,
10 mg/mL; 100
mL bag, Rx only
CLASS II
5-Aminolevulinic
Acid
Hydrochloride
active
pharmaceutical
ingredient
packaged in
varying grams or
kg in bags or
drums
4-Aminopyridine
active
pharmaceutical
ingredient
packaged in
varying grams or
kg in bags or
drums
Code info.
Class
C6; Exp
03/1/16
Lot: 42-120-JT,
Exp
01DEC2015
Reason for Recall
Recalling firm
Matter: Confirmed
finding of human hair
floating in IV solution.
Class I
Labeling: Wrong Bar
Code: There is a
potential for some units
to be mislabeled with an
incorrect barcode on the
immediate container
that scans as heparin
sodium 2000 USP
units/1000 mL in 0.9% in
sodium chloride
injection.
Hospira Inc.
All lots
Class II
repackaged
and distributed
between
01/05/12 to
02/12/15
Penicillin Cross
Contamination: All lots of
all products repackaged
and distributed between
01/05/12 and 02/12/15
are being recalled
because they were
repackaged in a facility
with penicillin products
without adequate
separation which could
introduce the potential
for cross contamination
with penicillin.
Penicillin Cross
Contamination: All lots of
all products repackaged
and distributed between
01/05/12 and 02/12/15
are being recalled
because they were
repackaged in a facility
with penicillin products
without adequate
separation which could
Attix
Pharmaceutic
als
All lots
Class II
repackaged
and distributed
between
01/05/12 to
02/12/15
Copyright© PerformRx, LLC 2015 All Rights Reserved
Attix
Pharmaceutic
als
19
Product
Type
Product
Description
Code info.
Class
Drugs
2-Deoxy-DGlucose active
pharmaceutical
ingredient
packaged in
varying grams or
kg in bags or
drums
All lots
Class II
repackaged
and distributed
between
01/05/12 to
02/12/15
Drugs
3,4Diaminopyridine
active
pharmaceutical
ingredient
packaged in
varying grams or
kg in bags or
drums
All lots
Class II
repackaged
and distributed
between
01/05/12 to
02/12/15
Drugs
2,3Dimercaptopropa
nesulfonic Acid
Sodium Salt
(DMPS) active
pharmaceutical
ingredient
packaged in
varying grams or
kg in bags or
All lots
Class II
repackaged
and distributed
between
01/05/12 to
02/12/15
Copyright© PerformRx, LLC 2015 All Rights Reserved
Reason for Recall
introduce the potential
for cross contamination
with penicillin.
Penicillin Cross
Contamination: All lots of
all products repackaged
and distributed between
01/05/12 and 02/12/15
are being recalled
because they were
repackaged in a facility
with penicillin products
without adequate
separation which could
introduce the potential
for cross contamination
with penicillin.
Penicillin Cross
Contamination: All lots of
all products repackaged
and distributed between
01/05/12 and 02/12/15
are being recalled
because they were
repackaged in a facility
with penicillin products
without adequate
separation which could
introduce the potential
for cross contamination
with penicillin.
Penicillin Cross
Contamination: All lots of
all products repackaged
and distributed between
01/05/12 and 02/12/15
are being recalled
because they were
repackaged in a facility
with penicillin products
without adequate
Recalling firm
Attix
Pharmaceutic
als
Attix
Pharmaceutic
als
Attix
Pharmaceutic
als
20
Product
Type
Product
Description
drums
Code info.
Class
Drugs
2,3Dimercaptosuccin
ic Acid (DMSA)
active
pharmaceutical
ingredient
packaged in
varying grams or
kg in bags or
drums
All lots
Class II
repackaged
and distributed
between
01/05/12 to
02/12/15
Drugs
5-Fluorouracil
active
pharmaceutical
ingredient
packaged in
varying grams or
kg in bags or
drums
All lots
Class II
repackaged
and distributed
between
01/05/12 to
02/12/15
Drugs
2Methoxyestradiol
active
pharmaceutical
ingredient
packaged in
varying grams or
kg in bags or
drums
All lots
Class II
repackaged
and distributed
between
01/05/12 to
02/12/15
Copyright© PerformRx, LLC 2015 All Rights Reserved
Reason for Recall
separation which could
introduce the potential
for cross contamination
with penicillin.
Penicillin Cross
Contamination: All lots of
all products repackaged
and distributed between
01/05/12 and 02/12/15
are being recalled
because they were
repackaged in a facility
with penicillin products
without adequate
separation which could
introduce the potential
for cross contamination
with penicillin.
Penicillin Cross
Contamination: All lots of
all products repackaged
and distributed between
01/05/12 and 02/12/15
are being recalled
because they were
repackaged in a facility
with penicillin products
without adequate
separation which could
introduce the potential
for cross contamination
with penicillin.
Penicillin Cross
Contamination: All lots of
all products repackaged
and distributed between
01/05/12 and 02/12/15
are being recalled
because they were
repackaged in a facility
with penicillin products
Recalling firm
Attix
Pharmaceutic
als
Attix
Pharmaceutic
als
Attix
Pharmaceutic
als
21
Product
Type
Product
Description
Code info.
Class
Drugs
Acetazolamide
active
pharmaceutical
ingredient
packaged in
varying grams or
kg in bags or
drums
All lots
Class II
repackaged
and distributed
between
01/05/12 to
02/12/15
Drugs
Acetylsalicyclic
acid active
pharmaceutical
ingredient
packaged in
varying grams or
kg in bags or
drums
All lots
Class II
repackaged
and distributed
between
01/05/12 to
02/12/15
Drugs
Acyclovir Sodium
active
pharmaceutical
ingredient
packaged in
varying grams or
kg in bags or
drums
All lots
Class II
repackaged
and distributed
between
01/05/12 to
02/12/15
Copyright© PerformRx, LLC 2015 All Rights Reserved
Reason for Recall
without adequate
separation which could
introduce the potential
for cross contamination
with penicillin.
Penicillin Cross
Contamination: All lots of
all products repackaged
and distributed between
01/05/12 and 02/12/15
are being recalled
because they were
repackaged in a facility
with penicillin products
without adequate
separation which could
introduce the potential
for cross contamination
with penicillin.
Penicillin Cross
Contamination: All lots of
all products repackaged
and distributed between
01/05/12 and 02/12/15
are being recalled
because they were
repackaged in a facility
with penicillin products
without adequate
separation which could
introduce the potential
for cross contamination
with penicillin.
Penicillin Cross
Contamination: All lots of
all products repackaged
and distributed between
01/05/12 and 02/12/15
are being recalled
because they were
repackaged in a facility
Recalling firm
Attix
Pharmaceutic
als
Attix
Pharmaceutic
als
Attix
Pharmaceutic
als
22
Product
Type
Product
Description
Code info.
Class
Drugs
Adapalene active
pharmaceutical
ingredient
packaged in
varying grams or
kg in bags or
drums
All lots
Class II
repackaged
and distributed
between
01/05/12 to
02/12/15
Drugs
Adenosine active
pharmaceutical
ingredient
packaged in
varying grams or
kg in bags or
drums
All lots
Class II
repackaged
and distributed
between
01/05/12 to
02/12/15
Drugs
Albendazole
active
pharmaceutical
ingredient
packaged in
varying grams or
kg in bags or
All lots
Class II
repackaged
and distributed
between
01/05/12 to
02/12/15
Copyright© PerformRx, LLC 2015 All Rights Reserved
Reason for Recall
with penicillin products
without adequate
separation which could
introduce the potential
for cross contamination
with penicillin.
Penicillin Cross
Contamination: All lots of
all products repackaged
and distributed between
01/05/12 and 02/12/15
are being recalled
because they were
repackaged in a facility
with penicillin products
without adequate
separation which could
introduce the potential
for cross contamination
with penicillin.
Penicillin Cross
Contamination: All lots of
all products repackaged
and distributed between
01/05/12 and 02/12/15
are being recalled
because they were
repackaged in a facility
with penicillin products
without adequate
separation which could
introduce the potential
for cross contamination
with penicillin.
Penicillin Cross
Contamination: All lots of
all products repackaged
and distributed between
01/05/12 and 02/12/15
are being recalled
because they were
Recalling firm
Attix
Pharmaceutic
als
Attix
Pharmaceutic
als
Attix
Pharmaceutic
als
23
Product
Type
Product
Description
drums
Code info.
Class
Drugs
Albumin (Bovine)
active
pharmaceutical
ingredient
packaged in
varying grams or
kg in bags or
drums
All lots
Class II
repackaged
and distributed
between
01/05/12 to
02/12/15
Drugs
Albuterol Sulfate
active
pharmaceutical
ingredient
packaged in
varying grams or
kg in bags or
drums
All lots
Class II
repackaged
and distributed
between
01/05/12 to
02/12/15
Drugs
Aldosterone
active
pharmaceutical
ingredient
packaged in
varying grams or
All lots
Class II
repackaged
and distributed
between
01/05/12 to
02/12/15
Copyright© PerformRx, LLC 2015 All Rights Reserved
Reason for Recall
repackaged in a facility
with penicillin products
without adequate
separation which could
introduce the potential
for cross contamination
with penicillin.
Penicillin Cross
Contamination: All lots of
all products repackaged
and distributed between
01/05/12 and 02/12/15
are being recalled
because they were
repackaged in a facility
with penicillin products
without adequate
separation which could
introduce the potential
for cross contamination
with penicillin.
Penicillin Cross
Contamination: All lots of
all products repackaged
and distributed between
01/05/12 and 02/12/15
are being recalled
because they were
repackaged in a facility
with penicillin products
without adequate
separation which could
introduce the potential
for cross contamination
with penicillin.
Penicillin Cross
Contamination: All lots of
all products repackaged
and distributed between
01/05/12 and 02/12/15
are being recalled
Recalling firm
Attix
Pharmaceutic
als
Attix
Pharmaceutic
als
Attix
Pharmaceutic
als
24
Product
Type
Product
Description
kg in bags or
drums
Code info.
Class
Drugs
Alpha
Chymotrypsin
active
pharmaceutical
ingredient
packaged in
varying grams or
kg in bags or
drums
All lots
Class II
repackaged
and distributed
between
01/05/12 to
02/12/15
Drugs
Amantadine HCl
active
pharmaceutical
ingredient
packaged in
varying grams or
kg in bags or
drums
All lots
Class II
repackaged
and distributed
between
01/05/12 to
02/12/15
Drugs
Ambroxol HCl
active
pharmaceutical
ingredient
packaged in
All lots
Class II
repackaged
and distributed
between
01/05/12 to
Copyright© PerformRx, LLC 2015 All Rights Reserved
Reason for Recall
because they were
repackaged in a facility
with penicillin products
without adequate
separation which could
introduce the potential
for cross contamination
with penicillin.
Penicillin Cross
Contamination: All lots of
all products repackaged
and distributed between
01/05/12 and 02/12/15
are being recalled
because they were
repackaged in a facility
with penicillin products
without adequate
separation which could
introduce the potential
for cross contamination
with penicillin.
Penicillin Cross
Contamination: All lots of
all products repackaged
and distributed between
01/05/12 and 02/12/15
are being recalled
because they were
repackaged in a facility
with penicillin products
without adequate
separation which could
introduce the potential
for cross contamination
with penicillin.
Penicillin Cross
Contamination: All lots of
all products repackaged
and distributed between
01/05/12 and 02/12/15
Recalling firm
Attix
Pharmaceutic
als
Attix
Pharmaceutic
als
Attix
Pharmaceutic
als
25
Product
Type
Product
Description
varying grams or
kg in bags or
drums
Code info.
Class
Drugs
Amikacin Sulfate
active
pharmaceutical
ingredient
packaged in
varying grams or
kg in bags or
drums
All lots
Class II
repackaged
and distributed
between
01/05/12 to
02/12/15
Drugs
Amiloride HCl
active
pharmaceutical
ingredient
packaged in
varying grams or
kg in bags or
drums
All lots
Class II
repackaged
and distributed
between
01/05/12 to
02/12/15
Drugs
Aminocaproic
Acid active
pharmaceutical
ingredient
All lots
Class II
repackaged
and distributed
between
02/12/15
Copyright© PerformRx, LLC 2015 All Rights Reserved
Reason for Recall
are being recalled
because they were
repackaged in a facility
with penicillin products
without adequate
separation which could
introduce the potential
for cross contamination
with penicillin.
Penicillin Cross
Contamination: All lots of
all products repackaged
and distributed between
01/05/12 and 02/12/15
are being recalled
because they were
repackaged in a facility
with penicillin products
without adequate
separation which could
introduce the potential
for cross contamination
with penicillin.
Penicillin Cross
Contamination: All lots of
all products repackaged
and distributed between
01/05/12 and 02/12/15
are being recalled
because they were
repackaged in a facility
with penicillin products
without adequate
separation which could
introduce the potential
for cross contamination
with penicillin.
Penicillin Cross
Contamination: All lots of
all products repackaged
and distributed between
Recalling firm
Attix
Pharmaceutic
als
Attix
Pharmaceutic
als
Attix
Pharmaceutic
als
26
Product
Type
Product
Description
packaged in
varying grams or
kg in bags or
drums
Code info.
Class
Drugs
Aminophylline
active
pharmaceutical
ingredient
packaged in
varying grams or
kg in bags or
drums
All lots
Class II
repackaged
and distributed
between
01/05/12 to
02/12/15
Drugs
Aminopyridine
active
pharmaceutical
ingredient
packaged in
varying grams or
kg in bags or
drums
All lots
Class II
repackaged
and distributed
between
01/05/12 to
02/12/15
Drugs
Amitriptyline HCl
active
pharmaceutical
All lots
Class II
repackaged
and distributed
01/05/12 to
02/12/15
Copyright© PerformRx, LLC 2015 All Rights Reserved
Reason for Recall
01/05/12 and 02/12/15
are being recalled
because they were
repackaged in a facility
with penicillin products
without adequate
separation which could
introduce the potential
for cross contamination
with penicillin.
Penicillin Cross
Contamination: All lots of
all products repackaged
and distributed between
01/05/12 and 02/12/15
are being recalled
because they were
repackaged in a facility
with penicillin products
without adequate
separation which could
introduce the potential
for cross contamination
with penicillin.
Penicillin Cross
Contamination: All lots of
all products repackaged
and distributed between
01/05/12 and 02/12/15
are being recalled
because they were
repackaged in a facility
with penicillin products
without adequate
separation which could
introduce the potential
for cross contamination
with penicillin.
Penicillin Cross
Contamination: All lots of
all products repackaged
Recalling firm
Attix
Pharmaceutic
als
Attix
Pharmaceutic
als
Attix
Pharmaceutic
als
27
Product
Type
Product
Description
ingredient
packaged in
varying grams or
kg in bags or
drums
Code info.
Class
Drugs
Amlodipine active
pharmaceutical
ingredient
packaged in
varying grams or
kg in bags or
drums
All lots
Class II
repackaged
and distributed
between
01/05/12 to
02/12/15
Drugs
Amlodipine
besylate active
pharmaceutical
ingredient
packaged in
varying grams or
kg in bags or
drums
All lots
Class II
repackaged
and distributed
between
01/05/12 to
02/12/15
Drugs
Ammonium
All lots
Tetrathiomolybda repackaged
between
01/05/12 to
02/12/15
Class II
Copyright© PerformRx, LLC 2015 All Rights Reserved
Reason for Recall
and distributed between
01/05/12 and 02/12/15
are being recalled
because they were
repackaged in a facility
with penicillin products
without adequate
separation which could
introduce the potential
for cross contamination
with penicillin.
Penicillin Cross
Contamination: All lots of
all products repackaged
and distributed between
01/05/12 and 02/12/15
are being recalled
because they were
repackaged in a facility
with penicillin products
without adequate
separation which could
introduce the potential
for cross contamination
with penicillin.
Penicillin Cross
Contamination: All lots of
all products repackaged
and distributed between
01/05/12 and 02/12/15
are being recalled
because they were
repackaged in a facility
with penicillin products
without adequate
separation which could
introduce the potential
for cross contamination
with penicillin.
Penicillin Cross
Contamination: All lots of
Recalling firm
Attix
Pharmaceutic
als
Attix
Pharmaceutic
als
Attix
Pharmaceutic
28
Product
Type
Product
Description
te active
pharmaceutical
ingredient
packaged in
varying grams or
kg in bags or
drums
Code info.
Class
Drugs
Amoxicillin
Trihydrate active
pharmaceutical
ingredient
packaged in
varying grams or
kg in bags or
drums
All lots
Class II
repackaged
and distributed
between
01/05/12 to
02/12/15
Drugs
Amphotericin B
active
pharmaceutical
ingredient
packaged in
varying grams or
kg in bags or
drums
All lots
Class II
repackaged
and distributed
between
01/05/12 to
02/12/15
Drugs
Anastrozole
active
pharmaceutical
ingredient
packaged in
All lots
Class II
repackaged
and distributed
between
01/05/12 to
and distributed
between
01/05/12 to
02/12/15
Copyright© PerformRx, LLC 2015 All Rights Reserved
Reason for Recall
Recalling firm
all products repackaged
and distributed between
01/05/12 and 02/12/15
are being recalled
because they were
repackaged in a facility
with penicillin products
without adequate
separation which could
introduce the potential
for cross contamination
with penicillin.
Stability Data Does Not
Support Expiry: All lots of
all products repackaged
and distributed between
01/05/12 through
02/12/15 are being
recalled because they
were repackaged
without data to support
the printed expiry date.
Penicillin Cross
Contamination: All lots of
all products repackaged
and distributed between
01/05/12 and 02/12/15
are being recalled
because they were
repackaged in a facility
with penicillin products
without adequate
separation which could
introduce the potential
for cross contamination
with penicillin.
Penicillin Cross
Contamination: All lots of
all products repackaged
and distributed between
01/05/12 and 02/12/15
als
Attix
Pharmaceutic
als
Attix
Pharmaceutic
als
Attix
Pharmaceutic
als
29
Product
Type
Product
Description
varying grams or
kg in bags or
drums
Code info.
Class
Drugs
Aprepitant active
pharmaceutical
ingredient
packaged in
varying grams or
kg in bags or
drums
All lots
Class II
repackaged
and distributed
between
01/05/12 to
02/12/15
Drugs
Artemether
active
pharmaceutical
ingredient
packaged in
varying grams or
kg in bags or
drums
All lots
Class II
repackaged
and distributed
between
01/05/12 to
02/12/15
Drugs
Artesunate active
pharmaceutical
ingredient
packaged in
All lots
Class II
repackaged
and distributed
between
02/12/15
Copyright© PerformRx, LLC 2015 All Rights Reserved
Reason for Recall
are being recalled
because they were
repackaged in a facility
with penicillin products
without adequate
separation which could
introduce the potential
for cross contamination
with penicillin.
Penicillin Cross
Contamination: All lots of
all products repackaged
and distributed between
01/05/12 and 02/12/15
are being recalled
because they were
repackaged in a facility
with penicillin products
without adequate
separation which could
introduce the potential
for cross contamination
with penicillin.
Penicillin Cross
Contamination: All lots of
all products repackaged
and distributed between
01/05/12 and 02/12/15
are being recalled
because they were
repackaged in a facility
with penicillin products
without adequate
separation which could
introduce the potential
for cross contamination
with penicillin.
Penicillin Cross
Contamination: All lots of
all products repackaged
and distributed between
Recalling firm
Attix
Pharmaceutic
als
Attix
Pharmaceutic
als
Attix
Pharmaceutic
als
30
Product
Type
Product
Description
varying grams or
kg in bags or
drums
Code info.
Class
Drugs
Atazanavir active
pharmaceutical
ingredient
packaged in
varying grams or
kg in bags or
drums
All lots
Class II
repackaged
and distributed
between
01/05/12 to
02/12/15
Drugs
Atomoxetine HCl
active
pharmaceutical
ingredient
packaged in
varying grams or
kg in bags or
drums
All lots
Class II
repackaged
and distributed
between
01/05/12 to
02/12/15
Drugs
Atovaquone
active
pharmaceutical
All lots
Class II
repackaged
and distributed
01/05/12 to
02/12/15
Copyright© PerformRx, LLC 2015 All Rights Reserved
Reason for Recall
01/05/12 and 02/12/15
are being recalled
because they were
repackaged in a facility
with penicillin products
without adequate
separation which could
introduce the potential
for cross contamination
with penicillin.
Penicillin Cross
Contamination: All lots of
all products repackaged
and distributed between
01/05/12 and 02/12/15
are being recalled
because they were
repackaged in a facility
with penicillin products
without adequate
separation which could
introduce the potential
for cross contamination
with penicillin.
Penicillin Cross
Contamination: All lots of
all products repackaged
and distributed between
01/05/12 and 02/12/15
are being recalled
because they were
repackaged in a facility
with penicillin products
without adequate
separation which could
introduce the potential
for cross contamination
with penicillin.
Penicillin Cross
Contamination: All lots of
all products repackaged
Recalling firm
Attix
Pharmaceutic
als
Attix
Pharmaceutic
als
Attix
Pharmaceutic
als
31
Product
Type
Product
Description
ingredient
packaged in
varying grams or
kg in bags or
drums
Code info.
Class
Drugs
Atropine Sulfate
Monohydrate
USP active
pharmaceutical
ingredient
packaged in
varying grams or
kg in bags or
drums
All lots
Class II
repackaged
and distributed
between
01/05/12 to
02/12/15
Drugs
Avanafil active
pharmaceutical
ingredient
packaged in
varying grams or
kg in bags or
drums
All lots
Class II
repackaged
and distributed
between
01/05/12 to
02/12/15
Drugs
Azatadine
Maleate active
All lots
repackaged
between
01/05/12 to
02/12/15
Class II
Copyright© PerformRx, LLC 2015 All Rights Reserved
Reason for Recall
and distributed between
01/05/12 and 02/12/15
are being recalled
because they were
repackaged in a facility
with penicillin products
without adequate
separation which could
introduce the potential
for cross contamination
with penicillin.
Penicillin Cross
Contamination: All lots of
all products repackaged
and distributed between
01/05/12 and 02/12/15
are being recalled
because they were
repackaged in a facility
with penicillin products
without adequate
separation which could
introduce the potential
for cross contamination
with penicillin.
Penicillin Cross
Contamination: All lots of
all products repackaged
and distributed between
01/05/12 and 02/12/15
are being recalled
because they were
repackaged in a facility
with penicillin products
without adequate
separation which could
introduce the potential
for cross contamination
with penicillin.
Penicillin Cross
Contamination: All lots of
Recalling firm
Attix
Pharmaceutic
als
Attix
Pharmaceutic
als
Attix
Pharmaceutic
32
Product
Type
Product
Description
pharmaceutical
ingredient
packaged in
varying grams or
kg in bags or
drums
Code info.
Class
Drugs
Azelastine HCl
active
pharmaceutical
ingredient
packaged in
varying grams or
kg in bags or
drums
All lots
Class II
repackaged
and distributed
between
01/05/12 to
02/12/15
Drugs
Azithromycin
Dihydrate active
pharmaceutical
ingredient
packaged in
varying grams or
kg in bags or
drums
All lots
Class II
repackaged
and distributed
between
01/05/12 to
02/12/15
Drugs
Baclofen active
All lots
and distributed
between
01/05/12 to
02/12/15
Class II
Copyright© PerformRx, LLC 2015 All Rights Reserved
Reason for Recall
Recalling firm
all products repackaged
and distributed between
01/05/12 and 02/12/15
are being recalled
because they were
repackaged in a facility
with penicillin products
without adequate
separation which could
introduce the potential
for cross contamination
with penicillin.
Penicillin Cross
Contamination: All lots of
all products repackaged
and distributed between
01/05/12 and 02/12/15
are being recalled
because they were
repackaged in a facility
with penicillin products
without adequate
separation which could
introduce the potential
for cross contamination
with penicillin.
Penicillin Cross
Contamination: All lots of
all products repackaged
and distributed between
01/05/12 and 02/12/15
are being recalled
because they were
repackaged in a facility
with penicillin products
without adequate
separation which could
introduce the potential
for cross contamination
with penicillin.
Penicillin Cross
als
Attix
Pharmaceutic
als
Attix
Pharmaceutic
als
Attix
33
Product
Type
Product
Description
pharmaceutical
ingredient
packaged in
varying grams or
kg in bags or
drums
Code info.
Class
Drugs
Belladonna
Extract Powder
active
pharmaceutical
ingredient
packaged in
varying grams or
kg in bags or
drums
All lots
Class II
repackaged
and distributed
between
01/05/12 to
02/12/15
Drugs
Benazepril active
pharmaceutical
ingredient
packaged in
varying grams or
kg in bags or
drums
All lots
Class II
repackaged
and distributed
between
01/05/12 to
02/12/15
repackaged
and distributed
between
01/05/12 to
02/12/15
Copyright© PerformRx, LLC 2015 All Rights Reserved
Reason for Recall
Recalling firm
Contamination: All lots of
all products repackaged
and distributed between
01/05/12 and 02/12/15
are being recalled
because they were
repackaged in a facility
with penicillin products
without adequate
separation which could
introduce the potential
for cross contamination
with penicillin.
Penicillin Cross
Contamination: All lots of
all products repackaged
and distributed between
01/05/12 and 02/12/15
are being recalled
because they were
repackaged in a facility
with penicillin products
without adequate
separation which could
introduce the potential
for cross contamination
with penicillin.
Penicillin Cross
Contamination: All lots of
all products repackaged
and distributed between
01/05/12 and 02/12/15
are being recalled
because they were
repackaged in a facility
with penicillin products
without adequate
separation which could
introduce the potential
for cross contamination
with penicillin.
Pharmaceutic
als
Attix
Pharmaceutic
als
Attix
Pharmaceutic
als
34
Product
Type
Drugs
Product
Description
Benazepril HCl
active
pharmaceutical
ingredient
packaged in
varying grams or
kg in bags or
drums
Code info.
Class
Drugs
Benoxinate HCl
active
pharmaceutical
ingredient
packaged in
varying grams or
kg in bags or
drums
All lots
Class II
repackaged
and distributed
between
01/05/12 to
02/12/15
Drugs
Benztropine
Mesylate active
pharmaceutical
ingredient
packaged in
varying grams or
kg in bags or
drums
All lots
Class II
repackaged
and distributed
between
01/05/12 to
02/12/15
All lots
Class II
repackaged
and distributed
between
01/05/12 to
02/12/15
Copyright© PerformRx, LLC 2015 All Rights Reserved
Reason for Recall
Recalling firm
Penicillin Cross
Contamination: All lots of
all products repackaged
and distributed between
01/05/12 and 02/12/15
are being recalled
because they were
repackaged in a facility
with penicillin products
without adequate
separation which could
introduce the potential
for cross contamination
with penicillin.
Penicillin Cross
Contamination: All lots of
all products repackaged
and distributed between
01/05/12 and 02/12/15
are being recalled
because they were
repackaged in a facility
with penicillin products
without adequate
separation which could
introduce the potential
for cross contamination
with penicillin.
Penicillin Cross
Contamination: All lots of
all products repackaged
and distributed between
01/05/12 and 02/12/15
are being recalled
because they were
repackaged in a facility
with penicillin products
without adequate
separation which could
introduce the potential
for cross contamination
Attix
Pharmaceutic
als
Attix
Pharmaceutic
als
Attix
Pharmaceutic
als
35
Product
Type
Product
Description
Code info.
Class
Drugs
Betahistine
Dihydrochloride
active
pharmaceutical
ingredient
packaged in
varying grams or
kg in bags or
drums
All lots
Class II
repackaged
and distributed
between
01/05/12 to
02/12/15
Drugs
Betamethasone
Sodium
Phosphate active
pharmaceutical
ingredient
packaged in
varying grams or
kg in bags or
drums
All lots
Class II
repackaged
and distributed
between
01/05/12 to
02/12/15
Drugs
Bethanechol
Chloride active
pharmaceutical
ingredient
packaged in
varying grams or
kg in bags or
drums
All lots
Class II
repackaged
and distributed
between
01/05/12 to
02/12/15
Copyright© PerformRx, LLC 2015 All Rights Reserved
Reason for Recall
with penicillin.
Penicillin Cross
Contamination: All lots of
all products repackaged
and distributed between
01/05/12 and 02/12/15
are being recalled
because they were
repackaged in a facility
with penicillin products
without adequate
separation which could
introduce the potential
for cross contamination
with penicillin.
Penicillin Cross
Contamination: All lots of
all products repackaged
and distributed between
01/05/12 and 02/12/15
are being recalled
because they were
repackaged in a facility
with penicillin products
without adequate
separation which could
introduce the potential
for cross contamination
with penicillin.
Penicillin Cross
Contamination: All lots of
all products repackaged
and distributed between
01/05/12 and 02/12/15
are being recalled
because they were
repackaged in a facility
with penicillin products
without adequate
separation which could
introduce the potential
Recalling firm
Attix
Pharmaceutic
als
Attix
Pharmaceutic
als
Attix
Pharmaceutic
als
36
Product
Type
Product
Description
Code info.
Class
Drugs
Bimatoprost
active
pharmaceutical
ingredient
packaged in
varying grams or
kg in bags or
drums
All lots
Class II
repackaged
and distributed
between
01/05/12 to
02/12/15
Drugs
Bisacodyl active
pharmaceutical
ingredient
packaged in
varying grams or
kg in bags or
drums
All lots
Class II
repackaged
and distributed
between
01/05/12 to
02/12/15
Drugs
Bismuth
Subcarbonate
active
pharmaceutical
ingredient
packaged in
varying grams or
kg in bags or
drums
All lots
Class II
repackaged
and distributed
between
01/05/12 to
02/12/15
Copyright© PerformRx, LLC 2015 All Rights Reserved
Reason for Recall
for cross contamination
with penicillin.
Penicillin Cross
Contamination: All lots of
all products repackaged
and distributed between
01/05/12 and 02/12/15
are being recalled
because they were
repackaged in a facility
with penicillin products
without adequate
separation which could
introduce the potential
for cross contamination
with penicillin.
Penicillin Cross
Contamination: All lots of
all products repackaged
and distributed between
01/05/12 and 02/12/15
are being recalled
because they were
repackaged in a facility
with penicillin products
without adequate
separation which could
introduce the potential
for cross contamination
with penicillin.
Penicillin Cross
Contamination: All lots of
all products repackaged
and distributed between
01/05/12 and 02/12/15
are being recalled
because they were
repackaged in a facility
with penicillin products
without adequate
separation which could
Recalling firm
Attix
Pharmaceutic
als
Attix
Pharmaceutic
als
Attix
Pharmaceutic
als
37
Product
Type
Product
Description
Code info.
Class
Drugs
Bovine Insulin
active
pharmaceutical
ingredient
packaged in
varying grams or
kg in bags or
drums
All lots
Class II
repackaged
and distributed
between
01/05/12 to
02/12/15
Drugs
Bromfenac
Sodium active
pharmaceutical
ingredient
packaged in
varying grams or
kg in bags or
drums
All lots
Class II
repackaged
and distributed
between
01/05/12 to
02/12/15
Drugs
Bromhexine HCl
active
pharmaceutical
ingredient
packaged in
varying grams or
kg in bags or
drums
All lots
Class II
repackaged
and distributed
between
01/05/12 to
02/12/15
Copyright© PerformRx, LLC 2015 All Rights Reserved
Reason for Recall
introduce the potential
for cross contamination
with penicillin.
Penicillin Cross
Contamination: All lots of
all products repackaged
and distributed between
01/05/12 and 02/12/15
are being recalled
because they were
repackaged in a facility
with penicillin products
without adequate
separation which could
introduce the potential
for cross contamination
with penicillin.
Penicillin Cross
Contamination: All lots of
all products repackaged
and distributed between
01/05/12 and 02/12/15
are being recalled
because they were
repackaged in a facility
with penicillin products
without adequate
separation which could
introduce the potential
for cross contamination
with penicillin.
Penicillin Cross
Contamination: All lots of
all products repackaged
and distributed between
01/05/12 and 02/12/15
are being recalled
because they were
repackaged in a facility
with penicillin products
without adequate
Recalling firm
Attix
Pharmaceutic
als
Attix
Pharmaceutic
als
Attix
Pharmaceutic
als
38
Product
Type
Product
Description
Code info.
Class
Drugs
Bromocriptine
Mesylate active
pharmaceutical
ingredient
packaged in
varying grams or
kg in bags or
drums
All lots
Class II
repackaged
and distributed
between
01/05/12 to
02/12/15
Drugs
Budesonide
active
pharmaceutical
ingredient
packaged in
varying grams or
kg in bags or
drums
All lots
Class II
repackaged
and distributed
between
01/05/12 to
02/12/15
Drugs
Bupivacaine
active
pharmaceutical
ingredient
packaged in
varying grams or
kg in bags or
drums
All lots
Class II
repackaged
and distributed
between
01/05/12 to
02/12/15
Copyright© PerformRx, LLC 2015 All Rights Reserved
Reason for Recall
separation which could
introduce the potential
for cross contamination
with penicillin.
Penicillin Cross
Contamination: All lots of
all products repackaged
and distributed between
01/05/12 and 02/12/15
are being recalled
because they were
repackaged in a facility
with penicillin products
without adequate
separation which could
introduce the potential
for cross contamination
with penicillin.
Penicillin Cross
Contamination: All lots of
all products repackaged
and distributed between
01/05/12 and 02/12/15
are being recalled
because they were
repackaged in a facility
with penicillin products
without adequate
separation which could
introduce the potential
for cross contamination
with penicillin.
Penicillin Cross
Contamination: All lots of
all products repackaged
and distributed between
01/05/12 and 02/12/15
are being recalled
because they were
repackaged in a facility
with penicillin products
Recalling firm
Attix
Pharmaceutic
als
Attix
Pharmaceutic
als
Attix
Pharmaceutic
als
39
Product
Type
Product
Description
Code info.
Class
Drugs
Bupivacaine HCl
active
pharmaceutical
ingredient
packaged in
varying grams or
kg in bags or
drums
All lots
Class II
repackaged
and distributed
between
01/05/12 to
02/12/15
Drugs
Bupropion HCI
active
pharmaceutical
ingredient
packaged in
varying grams or
kg in bags or
drums
All lots
Class II
repackaged
and distributed
between
01/05/12 to
02/12/15
Drugs
Cabergoline
active
pharmaceutical
ingredient
packaged in
varying grams or
kg in bags or
drums
All lots
Class II
repackaged
and distributed
between
01/05/12 to
02/12/15
Copyright© PerformRx, LLC 2015 All Rights Reserved
Reason for Recall
without adequate
separation which could
introduce the potential
for cross contamination
with penicillin.
Penicillin Cross
Contamination: All lots of
all products repackaged
and distributed between
01/05/12 and 02/12/15
are being recalled
because they were
repackaged in a facility
with penicillin products
without adequate
separation which could
introduce the potential
for cross contamination
with penicillin.
Penicillin Cross
Contamination: All lots of
all products repackaged
and distributed between
01/05/12 and 02/12/15
are being recalled
because they were
repackaged in a facility
with penicillin products
without adequate
separation which could
introduce the potential
for cross contamination
with penicillin.
Penicillin Cross
Contamination: All lots of
all products repackaged
and distributed between
01/05/12 and 02/12/15
are being recalled
because they were
repackaged in a facility
Recalling firm
Attix
Pharmaceutic
als
Attix
Pharmaceutic
als
Attix
Pharmaceutic
als
40
Product
Type
Product
Description
Code info.
Class
Drugs
Calcipotriene
active
pharmaceutical
ingredient
packaged in
varying grams or
kg in bags or
drums
All lots
Class II
repackaged
and distributed
between
01/05/12 to
02/12/15
Drugs
Calcitriol active
pharmaceutical
ingredient
packaged in
varying grams or
kg in bags or
drums
All lots
Class II
repackaged
and distributed
between
01/05/12 to
02/12/15
Drugs
Calcium Sulfate
Hemihydrate
active
pharmaceutical
ingredient
packaged in
varying grams or
All lots
Class II
repackaged
and distributed
between
01/05/12 to
02/12/15
Copyright© PerformRx, LLC 2015 All Rights Reserved
Reason for Recall
with penicillin products
without adequate
separation which could
introduce the potential
for cross contamination
with penicillin.
Penicillin Cross
Contamination: All lots of
all products repackaged
and distributed between
01/05/12 and 02/12/15
are being recalled
because they were
repackaged in a facility
with penicillin products
without adequate
separation which could
introduce the potential
for cross contamination
with penicillin.
Penicillin Cross
Contamination: All lots of
all products repackaged
and distributed between
01/05/12 and 02/12/15
are being recalled
because they were
repackaged in a facility
with penicillin products
without adequate
separation which could
introduce the potential
for cross contamination
with penicillin.
Penicillin Cross
Contamination: All lots of
all products repackaged
and distributed between
01/05/12 and 02/12/15
are being recalled
because they were
Recalling firm
Attix
Pharmaceutic
als
Attix
Pharmaceutic
als
Attix
Pharmaceutic
als
41
Product
Type
Product
Description
kg in bags or
drums
Code info.
Class
Drugs
Cantharidin
active
pharmaceutical
ingredient
packaged in
varying grams or
kg in bags or
drums
All lots
Class II
repackaged
and distributed
between
01/05/12 to
02/12/15
Drugs
Capecitabine
active
pharmaceutical
ingredient
packaged in
varying grams or
kg in bags or
drums
All lots
Class II
repackaged
and distributed
between
01/05/12 to
02/12/15
Drugs
Carbazochrome
active
pharmaceutical
ingredient
packaged in
varying grams or
All lots
Class II
repackaged
and distributed
between
01/05/12 to
02/12/15
Copyright© PerformRx, LLC 2015 All Rights Reserved
Reason for Recall
repackaged in a facility
with penicillin products
without adequate
separation which could
introduce the potential
for cross contamination
with penicillin.
Penicillin Cross
Contamination: All lots of
all products repackaged
and distributed between
01/05/12 and 02/12/15
are being recalled
because they were
repackaged in a facility
with penicillin products
without adequate
separation which could
introduce the potential
for cross contamination
with penicillin.
Penicillin Cross
Contamination: All lots of
all products repackaged
and distributed between
01/05/12 and 02/12/15
are being recalled
because they were
repackaged in a facility
with penicillin products
without adequate
separation which could
introduce the potential
for cross contamination
with penicillin.
Penicillin Cross
Contamination: All lots of
all products repackaged
and distributed between
01/05/12 and 02/12/15
are being recalled
Recalling firm
Attix
Pharmaceutic
als
Attix
Pharmaceutic
als
Attix
Pharmaceutic
als
42
Product
Type
Product
Description
kg in bags or
drums
Code info.
Class
Drugs
Carbimazole
active
pharmaceutical
ingredient
packaged in
varying grams or
kg in bags or
drums
All lots
Class II
repackaged
and distributed
between
01/05/12 to
02/12/15
Drugs
Carboplatin
active
pharmaceutical
ingredient
packaged in
varying grams or
kg in bags or
drums
All lots
repackaged
between
01/05/12 to
02/12/15
Drugs
Carboxymethyl
Cellulose Sodium
active
pharmaceutical
ingredient
All lots
Class II
repackaged
and distributed
between
01/05/12 to
Class II
Copyright© PerformRx, LLC 2015 All Rights Reserved
Reason for Recall
because they were
repackaged in a facility
with penicillin products
without adequate
separation which could
introduce the potential
for cross contamination
with penicillin.
Penicillin Cross
Contamination: All lots of
all products repackaged
and distributed between
01/05/12 and 02/12/15
are being recalled
because they were
repackaged in a facility
with penicillin products
without adequate
separation which could
introduce the potential
for cross contamination
with penicillin.
Penicillin Cross
Contamination: All lots of
all products repackaged
between 01/05/12
through 02/12/15 are
being recalled because
they were repackaged in
a facility with penicillin
products without
adequate separation
which could introduce
the potential for cross
contamination with
penicillin.
Penicillin Cross
Contamination: All lots of
all products repackaged
and distributed between
01/05/12 and 02/12/15
Recalling firm
Attix
Pharmaceutic
als
Attix
Pharmaceutic
als
Attix
Pharmaceutic
als
43
Product
Type
Product
Description
packaged in
varying grams or
kg in bags or
drums
Code info.
Class
Drugs
Carboxymethyl
Dextran active
pharmaceutical
ingredient
packaged in
varying grams or
kg in bags or
drums
All lots
Class II
repackaged
and distributed
between
01/05/12 to
02/12/15
Drugs
Carvedilol active
pharmaceutical
ingredient
packaged in
varying grams or
kg in bags or
drums
All lots
Class II
repackaged
and distributed
between
01/05/12 to
02/12/15
Drugs
Cefadroxil
Monohydrate
active
pharmaceutical
All lots
Class II
repackaged
and distributed
between
02/12/15
Copyright© PerformRx, LLC 2015 All Rights Reserved
Reason for Recall
are being recalled
because they were
repackaged in a facility
with penicillin products
without adequate
separation which could
introduce the potential
for cross contamination
with penicillin.
Penicillin Cross
Contamination: All lots of
all products repackaged
and distributed between
01/05/12 and 02/12/15
are being recalled
because they were
repackaged in a facility
with penicillin products
without adequate
separation which could
introduce the potential
for cross contamination
with penicillin.
Penicillin Cross
Contamination: All lots of
all products repackaged
and distributed between
01/05/12 and 02/12/15
are being recalled
because they were
repackaged in a facility
with penicillin products
without adequate
separation which could
introduce the potential
for cross contamination
with penicillin.
Penicillin Cross
Contamination: All lots of
all products repackaged
and distributed between
Recalling firm
Attix
Pharmaceutic
als
Attix
Pharmaceutic
als
Attix
Pharmaceutic
als
44
Product
Type
Product
Description
ingredient
packaged in
varying grams or
kg in bags or
drums
Code info.
Class
Drugs
Cefazolin Sodium
active
pharmaceutical
ingredient
packaged in
varying grams or
kg in bags or
drums
All lots
Class II
repackaged
and distributed
between
01/05/12 to
02/12/15
Drugs
Cefixime active
pharmaceutical
ingredient
packaged in
varying grams or
kg in bags or
drums
All lots
Class II
repackaged
and distributed
between
01/05/12 to
02/12/15
Drugs
Cefpodoxime
Proxetil active
pharmaceutical
All lots
Class II
repackaged
and distributed
01/05/12 to
02/12/15
Copyright© PerformRx, LLC 2015 All Rights Reserved
Reason for Recall
01/05/12 and 02/12/15
are being recalled
because they were
repackaged in a facility
with penicillin products
without adequate
separation which could
introduce the potential
for cross contamination
with penicillin.
Penicillin Cross
Contamination: All lots of
all products repackaged
and distributed between
01/05/12 and 02/12/15
are being recalled
because they were
repackaged in a facility
with penicillin products
without adequate
separation which could
introduce the potential
for cross contamination
with penicillin.
Penicillin Cross
Contamination: All lots of
all products repackaged
and distributed between
01/05/12 and 02/12/15
are being recalled
because they were
repackaged in a facility
with penicillin products
without adequate
separation which could
introduce the potential
for cross contamination
with penicillin.
Penicillin Cross
Contamination: All lots of
all products repackaged
Recalling firm
Attix
Pharmaceutic
als
Attix
Pharmaceutic
als
Attix
Pharmaceutic
als
45
Product
Type
Product
Description
ingredient
packaged in
varying grams or
kg in bags or
drums
Code info.
Class
Drugs
Celecoxib active
pharmaceutical
ingredient
packaged in
varying grams or
kg in bags or
drums
All lots
Class II
repackaged
and distributed
between
01/05/12 to
02/12/15
Drugs
Cephalexin active
pharmaceutical
ingredient
packaged in
varying grams or
kg in bags or
drums
All lots
Class II
repackaged
and distributed
between
01/05/12 to
02/12/15
Drugs
Cephalexin
Monohydrate
All lots
repackaged
between
01/05/12 to
02/12/15
Class II
Copyright© PerformRx, LLC 2015 All Rights Reserved
Reason for Recall
and distributed between
01/05/12 and 02/12/15
are being recalled
because they were
repackaged in a facility
with penicillin products
without adequate
separation which could
introduce the potential
for cross contamination
with penicillin.
Penicillin Cross
Contamination: All lots of
all products repackaged
and distributed between
01/05/12 and 02/12/15
are being recalled
because they were
repackaged in a facility
with penicillin products
without adequate
separation which could
introduce the potential
for cross contamination
with penicillin.
Penicillin Cross
Contamination: All lots of
all products repackaged
and distributed between
01/05/12 and 02/12/15
are being recalled
because they were
repackaged in a facility
with penicillin products
without adequate
separation which could
introduce the potential
for cross contamination
with penicillin.
Penicillin Cross
Contamination: All lots of
Recalling firm
Attix
Pharmaceutic
als
Attix
Pharmaceutic
als
Attix
Pharmaceutic
46
Product
Type
Product
Description
active
pharmaceutical
ingredient
packaged in
varying grams or
kg in bags or
drums
Code info.
Class
Drugs
Cetirizine HCI
active
pharmaceutical
ingredient
packaged in
varying grams or
kg in bags or
drums
All lots
Class II
repackaged
and distributed
between
01/05/12 to
02/12/15
Drugs
Chlorambucil
active
pharmaceutical
ingredient
packaged in
varying grams or
kg in bags or
drums
All lots
Class II
repackaged
and distributed
between
01/05/12 to
02/12/15
Drugs
Chloramphenicol
All lots
and distributed
between
01/05/12 to
02/12/15
Class II
Copyright© PerformRx, LLC 2015 All Rights Reserved
Reason for Recall
Recalling firm
all products repackaged
and distributed between
01/05/12 and 02/12/15
are being recalled
because they were
repackaged in a facility
with penicillin products
without adequate
separation which could
introduce the potential
for cross contamination
with penicillin.
Penicillin Cross
Contamination: All lots of
all products repackaged
and distributed between
01/05/12 and 02/12/15
are being recalled
because they were
repackaged in a facility
with penicillin products
without adequate
separation which could
introduce the potential
for cross contamination
with penicillin.
Penicillin Cross
Contamination: All lots of
all products repackaged
and distributed between
01/05/12 and 02/12/15
are being recalled
because they were
repackaged in a facility
with penicillin products
without adequate
separation which could
introduce the potential
for cross contamination
with penicillin.
Penicillin Cross
als
Attix
Pharmaceutic
als
Attix
Pharmaceutic
als
Attix
47
Product
Type
Product
Description
active
pharmaceutical
ingredient
packaged in
varying grams or
kg in bags or
drums
Code info.
Class
Drugs
Chloramphenicol
Palmitate active
pharmaceutical
ingredient
packaged in
varying grams or
kg in bags or
drums
All lots
Class II
repackaged
and distributed
between
01/05/12 to
02/12/15
Drugs
Chlorobutanol
Anhydrous
pharmaceutical
ingredient
packaged in
varying grams or
kg in bags or
drums
All lots
Class II
repackaged
and distributed
between
01/05/12 to
02/12/15
repackaged
and distributed
between
01/05/12 to
02/12/15
Copyright© PerformRx, LLC 2015 All Rights Reserved
Reason for Recall
Recalling firm
Contamination: All lots of
all products repackaged
and distributed between
01/05/12 and 02/12/15
are being recalled
because they were
repackaged in a facility
with penicillin products
without adequate
separation which could
introduce the potential
for cross contamination
with penicillin.
Penicillin Cross
Contamination: All lots of
all products repackaged
and distributed between
01/05/12 and 02/12/15
are being recalled
because they were
repackaged in a facility
with penicillin products
without adequate
separation which could
introduce the potential
for cross contamination
with penicillin.
Penicillin Cross
Contamination: All lots of
all products repackaged
and distributed between
01/05/12 and 02/12/15
are being recalled
because they were
repackaged in a facility
with penicillin products
without adequate
separation which could
introduce the potential
for cross contamination
with penicillin.
Pharmaceutic
als
Attix
Pharmaceutic
als
Attix
Pharmaceutic
als
48
Product
Type
Drugs
Product
Description
Chlorobutanol
Hemihydrate
pharmaceutical
ingredient
packaged in
varying grams or
kg in bags or
drums
Code info.
Class
Drugs
Chloroquine
Phosphate active
pharmaceutical
ingredient
packaged in
varying grams or
kg in bags or
drums
All lots
Class II
repackaged
and distributed
between
01/05/12 to
02/12/15
Drugs
Chloroxine active
pharmaceutical
ingredient
packaged in
varying grams or
kg in bags or
drums
All lots
Class II
repackaged
and distributed
between
01/05/12 to
02/12/15
All lots
Class II
repackaged
and distributed
between
01/05/12 to
02/12/15
Copyright© PerformRx, LLC 2015 All Rights Reserved
Reason for Recall
Recalling firm
Penicillin Cross
Contamination: All lots of
all products repackaged
and distributed between
01/05/12 and 02/12/15
are being recalled
because they were
repackaged in a facility
with penicillin products
without adequate
separation which could
introduce the potential
for cross contamination
with penicillin.
Penicillin Cross
Contamination: All lots of
all products repackaged
and distributed between
01/05/12 and 02/12/15
are being recalled
because they were
repackaged in a facility
with penicillin products
without adequate
separation which could
introduce the potential
for cross contamination
with penicillin.
Penicillin Cross
Contamination: All lots of
all products repackaged
and distributed between
01/05/12 and 02/12/15
are being recalled
because they were
repackaged in a facility
with penicillin products
without adequate
separation which could
introduce the potential
for cross contamination
Attix
Pharmaceutic
als
Attix
Pharmaceutic
als
Attix
Pharmaceutic
als
49
Product
Type
Product
Description
Code info.
Class
Drugs
Chlorpromazine
HCl active
pharmaceutical
ingredient
packaged in
varying grams or
kg in bags or
drums
All lots
Class II
repackaged
and distributed
between
01/05/12 to
02/12/15
Drugs
Cholestyramine
active
pharmaceutical
ingredient
packaged in
varying grams or
kg in bags or
drums
All lots
Class II
repackaged
and distributed
between
01/05/12 to
02/12/15
Drugs
Cidofovir
Anhydrous active
pharmaceutical
ingredient
packaged in
varying grams or
kg in bags or
drums
All lots
Class II
repackaged
and distributed
between
01/05/12 to
02/12/15
Copyright© PerformRx, LLC 2015 All Rights Reserved
Reason for Recall
with penicillin.
Penicillin Cross
Contamination: All lots of
all products repackaged
and distributed between
01/05/12 and 02/12/15
are being recalled
because they were
repackaged in a facility
with penicillin products
without adequate
separation which could
introduce the potential
for cross contamination
with penicillin.
Penicillin Cross
Contamination: All lots of
all products repackaged
and distributed between
01/05/12 and 02/12/15
are being recalled
because they were
repackaged in a facility
with penicillin products
without adequate
separation which could
introduce the potential
for cross contamination
with penicillin.
Penicillin Cross
Contamination: All lots of
all products repackaged
and distributed between
01/05/12 and 02/12/15
are being recalled
because they were
repackaged in a facility
with penicillin products
without adequate
separation which could
introduce the potential
Recalling firm
Attix
Pharmaceutic
als
Attix
Pharmaceutic
als
Attix
Pharmaceutic
als
50
Product
Type
Product
Description
Code info.
Class
Drugs
Cidofovir
Dihydrate active
pharmaceutical
ingredient
packaged in
varying grams or
kg in bags or
drums
All lots
Class II
repackaged
and distributed
between
01/05/12 to
02/12/15
Drugs
Cilostazol active
pharmaceutical
ingredient
packaged in
varying grams or
kg in bags or
drums
All lots
Class II
repackaged
and distributed
between
01/05/12 to
02/12/15
Drugs
Cimetidine active
pharmaceutical
ingredient
packaged in
varying grams or
kg in bags or
drums
All lots
Class II
repackaged
and distributed
between
01/05/12 to
02/12/15
Copyright© PerformRx, LLC 2015 All Rights Reserved
Reason for Recall
for cross contamination
with penicillin.
Penicillin Cross
Contamination: All lots of
all products repackaged
and distributed between
01/05/12 and 02/12/15
are being recalled
because they were
repackaged in a facility
with penicillin products
without adequate
separation which could
introduce the potential
for cross contamination
with penicillin.
Penicillin Cross
Contamination: All lots of
all products repackaged
and distributed between
01/05/12 and 02/12/15
are being recalled
because they were
repackaged in a facility
with penicillin products
without adequate
separation which could
introduce the potential
for cross contamination
with penicillin.
Penicillin Cross
Contamination: All lots of
all products repackaged
and distributed between
01/05/12 and 02/12/15
are being recalled
because they were
repackaged in a facility
with penicillin products
without adequate
separation which could
Recalling firm
Attix
Pharmaceutic
als
Attix
Pharmaceutic
als
Attix
Pharmaceutic
als
51
Product
Type
Product
Description
Code info.
Class
Drugs
Cinacalcet HCI
active
pharmaceutical
ingredient
packaged in
varying grams or
kg in bags or
drums
All lots
Class II
repackaged
and distributed
between
01/05/12 to
02/12/15
Drugs
Ciprofloxacin HCl
active
pharmaceutical
ingredient
packaged in
varying grams or
kg in bags or
drums
All lots
Class II
repackaged
and distributed
between
01/05/12 to
02/12/15
Drugs
Cisatracurium
Besylate active
pharmaceutical
ingredient
packaged in
varying grams or
kg in bags or
drums
All lots
Class II
repackaged
and distributed
between
01/05/12 to
02/12/15
Copyright© PerformRx, LLC 2015 All Rights Reserved
Reason for Recall
introduce the potential
for cross contamination
with penicillin.
Penicillin Cross
Contamination: All lots of
all products repackaged
and distributed between
01/05/12 and 02/12/15
are being recalled
because they were
repackaged in a facility
with penicillin products
without adequate
separation which could
introduce the potential
for cross contamination
with penicillin.
Penicillin Cross
Contamination: All lots of
all products repackaged
and distributed between
01/05/12 and 02/12/15
are being recalled
because they were
repackaged in a facility
with penicillin products
without adequate
separation which could
introduce the potential
for cross contamination
with penicillin.
Penicillin Cross
Contamination: All lots of
all products repackaged
and distributed between
01/05/12 and 02/12/15
are being recalled
because they were
repackaged in a facility
with penicillin products
without adequate
Recalling firm
Attix
Pharmaceutic
als
Attix
Pharmaceutic
als
Attix
Pharmaceutic
als
52
Product
Type
Product
Description
Code info.
Class
Drugs
Cisplatin active
pharmaceutical
ingredient
packaged in
varying grams or
kg in bags or
drums
All lots
Class II
repackaged
and distributed
between
01/05/12 to
02/12/15
Drugs
Citalopram
Hydrobromide
active
pharmaceutical
ingredient
packaged in
varying grams or
kg in bags or
drums
All lots
repackaged
between
01/05/12 to
02/12/15
Drugs
Clarithromycin
active
pharmaceutical
ingredient
packaged in
varying grams or
kg in bags or
drums
All lots
Class II
repackaged
and distributed
between
01/05/12 to
02/12/15
Class II
Copyright© PerformRx, LLC 2015 All Rights Reserved
Reason for Recall
separation which could
introduce the potential
for cross contamination
with penicillin.
Penicillin Cross
Contamination: All lots of
all products repackaged
and distributed between
01/05/12 and 02/12/15
are being recalled
because they were
repackaged in a facility
with penicillin products
without adequate
separation which could
introduce the potential
for cross contamination
with penicillin.
Penicillin Cross
Contamination: All lots of
all products repackaged
between 01/05/12
through 02/12/15 are
being recalled because
they were repackaged in
a facility with penicillin
products without
adequate separation
which could introduce
the potential for cross
contamination with
penicillin.
Penicillin Cross
Contamination: All lots of
all products repackaged
and distributed between
01/05/12 and 02/12/15
are being recalled
because they were
repackaged in a facility
with penicillin products
Recalling firm
Attix
Pharmaceutic
als
Attix
Pharmaceutic
als
Attix
Pharmaceutic
als
53
Product
Type
Product
Description
Code info.
Class
Drugs
Clindamycin HCl
active
pharmaceutical
ingredient
packaged in
varying grams or
kg in bags or
drums
All lots
Class II
repackaged
and distributed
between
01/05/12 to
02/12/15
Drugs
Clomiphene
Citrate active
pharmaceutical
ingredient
packaged in
varying grams or
kg in bags or
drums
All lots
Class II
repackaged
and distributed
between
01/05/12 to
02/12/15
Drugs
Clomipramine
HCI active
pharmaceutical
ingredient
packaged in
varying grams or
kg in bags or
drums
All lots
Class II
repackaged
and distributed
between
01/05/12 to
02/12/15
Copyright© PerformRx, LLC 2015 All Rights Reserved
Reason for Recall
without adequate
separation which could
introduce the potential
for cross contamination
with penicillin.
Penicillin Cross
Contamination: All lots of
all products repackaged
and distributed between
01/05/12 and 02/12/15
are being recalled
because they were
repackaged in a facility
with penicillin products
without adequate
separation which could
introduce the potential
for cross contamination
with penicillin.
Penicillin Cross
Contamination: All lots of
all products repackaged
and distributed between
01/05/12 and 02/12/15
are being recalled
because they were
repackaged in a facility
with penicillin products
without adequate
separation which could
introduce the potential
for cross contamination
with penicillin.
Penicillin Cross
Contamination: All lots of
all products repackaged
and distributed between
01/05/12 and 02/12/15
are being recalled
because they were
repackaged in a facility
Recalling firm
Attix
Pharmaceutic
als
Attix
Pharmaceutic
als
Attix
Pharmaceutic
als
54
Product
Type
Product
Description
Code info.
Class
Drugs
Clonidine HCl
active
pharmaceutical
ingredient
packaged in
varying grams or
kg in bags or
drums
All lots
Class II
repackaged
and distributed
between
01/05/12 to
02/12/15
Drugs
Clopidogrel
Bisulfate active
pharmaceutical
ingredient
packaged in
varying grams or
kg in bags or
drums
All lots
Class II
repackaged
and distributed
between
01/05/12 to
02/12/15
Drugs
Clozapine active
pharmaceutical
ingredient
packaged in
varying grams or
kg in bags or
drums
All lots
Class II
repackaged
and distributed
between
01/05/12 to
02/12/15
Copyright© PerformRx, LLC 2015 All Rights Reserved
Reason for Recall
with penicillin products
without adequate
separation which could
introduce the potential
for cross contamination
with penicillin.
Penicillin Cross
Contamination: All lots of
all products repackaged
and distributed between
01/05/12 and 02/12/15
are being recalled
because they were
repackaged in a facility
with penicillin products
without adequate
separation which could
introduce the potential
for cross contamination
with penicillin.
Penicillin Cross
Contamination: All lots of
all products repackaged
and distributed between
01/05/12 and 02/12/15
are being recalled
because they were
repackaged in a facility
with penicillin products
without adequate
separation which could
introduce the potential
for cross contamination
with penicillin.
Penicillin Cross
Contamination: All lots of
all products repackaged
and distributed between
01/05/12 and 02/12/15
are being recalled
because they were
Recalling firm
Attix
Pharmaceutic
als
Attix
Pharmaceutic
als
Attix
Pharmaceutic
als
55
Product
Type
Product
Description
Code info.
Class
Drugs
Colchicine active
pharmaceutical
ingredient
packaged in
varying grams or
kg in bags or
drums
All lots
Class II
repackaged
and distributed
between
01/05/12 to
02/12/15
Drugs
Cortisone Acetate
Micronized active
pharmaceutical
ingredient
packaged in
varying grams or
kg in bags or
drums
All lots
Class II
repackaged
and distributed
between
01/05/12 to
02/12/15
Drugs
Croscarmellose
Sodium
pharmaceutical
ingredient
packaged in
varying grams or
All lots
Class II
repackaged
and distributed
between
01/05/12 to
02/12/15
Copyright© PerformRx, LLC 2015 All Rights Reserved
Reason for Recall
repackaged in a facility
with penicillin products
without adequate
separation which could
introduce the potential
for cross contamination
with penicillin.
Penicillin Cross
Contamination: All lots of
all products repackaged
and distributed between
01/05/12 and 02/12/15
are being recalled
because they were
repackaged in a facility
with penicillin products
without adequate
separation which could
introduce the potential
for cross contamination
with penicillin.
Penicillin Cross
Contamination: All lots of
all products repackaged
and distributed between
01/05/12 and 02/12/15
are being recalled
because they were
repackaged in a facility
with penicillin products
without adequate
separation which could
introduce the potential
for cross contamination
with penicillin.
Penicillin Cross
Contamination: All lots of
all products repackaged
and distributed between
01/05/12 and 02/12/15
are being recalled
Recalling firm
Attix
Pharmaceutic
als
Attix
Pharmaceutic
als
Attix
Pharmaceutic
als
56
Product
Type
Product
Description
kg in bags or
drums
Code info.
Class
Drugs
Crospovidone
pharmaceutical
ingredient
packaged in
varying grams or
kg in bags or
drums
All lots
Class II
repackaged
and distributed
between
01/05/12 to
02/12/15
Drugs
Crotamiton active
pharmaceutical
ingredient
packaged in
varying grams or
kg in bags or
drums
All lots
Class II
repackaged
and distributed
between
01/05/12 to
02/12/15
Drugs
Cyanocobalamin
active
pharmaceutical
ingredient
packaged in
All lots
Class II
repackaged
and distributed
between
01/05/12 to
Copyright© PerformRx, LLC 2015 All Rights Reserved
Reason for Recall
because they were
repackaged in a facility
with penicillin products
without adequate
separation which could
introduce the potential
for cross contamination
with penicillin.
Penicillin Cross
Contamination: All lots of
all products repackaged
and distributed between
01/05/12 and 02/12/15
are being recalled
because they were
repackaged in a facility
with penicillin products
without adequate
separation which could
introduce the potential
for cross contamination
with penicillin.
Penicillin Cross
Contamination: All lots of
all products repackaged
and distributed between
01/05/12 and 02/12/15
are being recalled
because they were
repackaged in a facility
with penicillin products
without adequate
separation which could
introduce the potential
for cross contamination
with penicillin.
Penicillin Cross
Contamination: All lots of
all products repackaged
and distributed between
01/05/12 and 02/12/15
Recalling firm
Attix
Pharmaceutic
als
Attix
Pharmaceutic
als
Attix
Pharmaceutic
als
57
Product
Type
Product
Description
varying grams or
kg in bags or
drums
Code info.
Class
Drugs
Cyclobenzaprine
HCI active
pharmaceutical
ingredient
packaged in
varying grams or
kg in bags or
drums
All lots
Class II
repackaged
and distributed
between
01/05/12 to
02/12/15
Drugs
Cyclophosphamid
e Monohydrate
active
pharmaceutical
ingredient
packaged in
varying grams or
kg in bags or
drums
All lots
Class II
repackaged
and distributed
between
01/05/12 to
02/12/15
Drugs
Cyclosporine A
active
pharmaceutical
ingredient
All lots
Class II
repackaged
and distributed
between
02/12/15
Copyright© PerformRx, LLC 2015 All Rights Reserved
Reason for Recall
are being recalled
because they were
repackaged in a facility
with penicillin products
without adequate
separation which could
introduce the potential
for cross contamination
with penicillin.
Penicillin Cross
Contamination: All lots of
all products repackaged
and distributed between
01/05/12 and 02/12/15
are being recalled
because they were
repackaged in a facility
with penicillin products
without adequate
separation which could
introduce the potential
for cross contamination
with penicillin.
Penicillin Cross
Contamination: All lots of
all products repackaged
and distributed between
01/05/12 and 02/12/15
are being recalled
because they were
repackaged in a facility
with penicillin products
without adequate
separation which could
introduce the potential
for cross contamination
with penicillin.
Penicillin Cross
Contamination: All lots of
all products repackaged
and distributed between
Recalling firm
Attix
Pharmaceutic
als
Attix
Pharmaceutic
als
Attix
Pharmaceutic
als
58
Product
Type
Product
Description
packaged in
varying grams or
kg in bags or
drums
Code info.
Class
Drugs
D-Cycloserine
active
pharmaceutical
ingredient
packaged in
varying grams or
kg in bags or
drums
All lots
Class II
repackaged
and distributed
between
01/05/12 to
02/12/15
Drugs
Dacarbazine
active
pharmaceutical
ingredient
packaged in
varying grams or
kg in bags or
drums
All lots
Class II
repackaged
and distributed
between
01/05/12 to
02/12/15
Drugs
Dantrolene
Sodium active
pharmaceutical
All lots
Class II
repackaged
and distributed
01/05/12 to
02/12/15
Copyright© PerformRx, LLC 2015 All Rights Reserved
Reason for Recall
01/05/12 and 02/12/15
are being recalled
because they were
repackaged in a facility
with penicillin products
without adequate
separation which could
introduce the potential
for cross contamination
with penicillin.
Penicillin Cross
Contamination: All lots of
all products repackaged
and distributed between
01/05/12 and 02/12/15
are being recalled
because they were
repackaged in a facility
with penicillin products
without adequate
separation which could
introduce the potential
for cross contamination
with penicillin.
Penicillin Cross
Contamination: All lots of
all products repackaged
and distributed between
01/05/12 and 02/12/15
are being recalled
because they were
repackaged in a facility
with penicillin products
without adequate
separation which could
introduce the potential
for cross contamination
with penicillin.
Penicillin Cross
Contamination: All lots of
all products repackaged
Recalling firm
Attix
Pharmaceutic
als
Attix
Pharmaceutic
als
Attix
Pharmaceutic
als
59
Product
Type
Product
Description
ingredient
packaged in
varying grams or
kg in bags or
drums
Code info.
Class
Drugs
Dantrolene
Sodium (Light
Yellow) active
pharmaceutical
ingredient
packaged in
varying grams or
kg in bags or
drums
All lots
Class II
repackaged
and distributed
between
01/05/12 to
02/12/15
Drugs
Dantrolene
Sodium (Orange)
active
pharmaceutical
ingredient
packaged in
varying grams or
kg in bags or
drums
All lots
Class II
repackaged
and distributed
between
01/05/12 to
02/12/15
Drugs
Dapiprazole HCl
active
All lots
repackaged
between
01/05/12 to
02/12/15
Class II
Copyright© PerformRx, LLC 2015 All Rights Reserved
Reason for Recall
and distributed between
01/05/12 and 02/12/15
are being recalled
because they were
repackaged in a facility
with penicillin products
without adequate
separation which could
introduce the potential
for cross contamination
with penicillin.
Penicillin Cross
Contamination: All lots of
all products repackaged
and distributed between
01/05/12 and 02/12/15
are being recalled
because they were
repackaged in a facility
with penicillin products
without adequate
separation which could
introduce the potential
for cross contamination
with penicillin.
Penicillin Cross
Contamination: All lots of
all products repackaged
and distributed between
01/05/12 and 02/12/15
are being recalled
because they were
repackaged in a facility
with penicillin products
without adequate
separation which could
introduce the potential
for cross contamination
with penicillin.
Penicillin Cross
Contamination: All lots of
Recalling firm
Attix
Pharmaceutic
als
Attix
Pharmaceutic
als
Attix
Pharmaceutic
60
Product
Type
Product
Description
pharmaceutical
ingredient
packaged in
varying grams or
kg in bags or
drums
Code info.
Class
Drugs
Dapsone active
pharmaceutical
ingredient
packaged in
varying grams or
kg in bags or
drums
All lots
Class II
repackaged
and distributed
between
01/05/12 to
02/12/15
Drugs
Daptomycin
active
pharmaceutical
ingredient
packaged in
varying grams or
kg in bags or
drums
All lots
Class II
repackaged
and distributed
between
01/05/12 to
02/12/15
Drugs
Darunavir active
All lots
and distributed
between
01/05/12 to
02/12/15
Class II
Copyright© PerformRx, LLC 2015 All Rights Reserved
Reason for Recall
Recalling firm
all products repackaged
and distributed between
01/05/12 and 02/12/15
are being recalled
because they were
repackaged in a facility
with penicillin products
without adequate
separation which could
introduce the potential
for cross contamination
with penicillin.
Penicillin Cross
Contamination: All lots of
all products repackaged
and distributed between
01/05/12 and 02/12/15
are being recalled
because they were
repackaged in a facility
with penicillin products
without adequate
separation which could
introduce the potential
for cross contamination
with penicillin.
Penicillin Cross
Contamination: All lots of
all products repackaged
and distributed between
01/05/12 and 02/12/15
are being recalled
because they were
repackaged in a facility
with penicillin products
without adequate
separation which could
introduce the potential
for cross contamination
with penicillin.
Penicillin Cross
als
Attix
Pharmaceutic
als
Attix
Pharmaceutic
als
Attix
61
Product
Type
Product
Description
pharmaceutical
ingredient
packaged in
varying grams or
kg in bags or
drums
Code info.
Class
Drugs
Dasatinib active
pharmaceutical
ingredient
packaged in
varying grams or
kg in bags or
drums
All lots
Class II
repackaged
and distributed
between
01/05/12 to
02/12/15
Drugs
Demecarium
Bromide active
pharmaceutical
ingredient
packaged in
varying grams or
kg in bags or
drums
All lots
Class II
repackaged
and distributed
between
01/05/12 to
02/12/15
repackaged
and distributed
between
01/05/12 to
02/12/15
Copyright© PerformRx, LLC 2015 All Rights Reserved
Reason for Recall
Recalling firm
Contamination: All lots of
all products repackaged
and distributed between
01/05/12 and 02/12/15
are being recalled
because they were
repackaged in a facility
with penicillin products
without adequate
separation which could
introduce the potential
for cross contamination
with penicillin.
Penicillin Cross
Contamination: All lots of
all products repackaged
and distributed between
01/05/12 and 02/12/15
are being recalled
because they were
repackaged in a facility
with penicillin products
without adequate
separation which could
introduce the potential
for cross contamination
with penicillin.
Penicillin Cross
Contamination: All lots of
all products repackaged
and distributed between
01/05/12 and 02/12/15
are being recalled
because they were
repackaged in a facility
with penicillin products
without adequate
separation which could
introduce the potential
for cross contamination
with penicillin.
Pharmaceutic
als
Attix
Pharmaceutic
als
Attix
Pharmaceutic
als
62
Product
Type
Drugs
Product
Description
Demeclocycline
HCl active
pharmaceutical
ingredient
packaged in
varying grams or
kg in bags or
drums
Code info.
Class
Reason for Recall
Recalling firm
All lots
repackaged
between
01/05/12 to
02/12/15
Class II
Attix
Pharmaceutic
als
Drugs
Desmopressin
Acetate active
pharmaceutical
ingredient
packaged in
varying grams or
kg in bags or
drums
All lots
Class II
repackaged
and distributed
between
01/05/12 to
02/12/15
Drugs
Desonide active
pharmaceutical
ingredient
packaged in
varying grams or
kg in bags or
drums
All lots
Class II
repackaged
and distributed
between
01/05/12 to
02/12/15
Penicillin Cross
Contamination: All lots of
all products repackaged
between 01/05/12
through 02/12/15 are
being recalled because
they were repackaged in
a facility with penicillin
products without
adequate separation
which could introduce
the potential for cross
contamination with
penicillin.
Penicillin Cross
Contamination: All lots of
all products repackaged
and distributed between
01/05/12 and 02/12/15
are being recalled
because they were
repackaged in a facility
with penicillin products
without adequate
separation which could
introduce the potential
for cross contamination
with penicillin.
Penicillin Cross
Contamination: All lots of
all products repackaged
and distributed between
01/05/12 and 02/12/15
are being recalled
because they were
repackaged in a facility
with penicillin products
without adequate
separation which could
introduce the potential
for cross contamination
Copyright© PerformRx, LLC 2015 All Rights Reserved
Attix
Pharmaceutic
als
Attix
Pharmaceutic
als
63
Product
Type
Product
Description
Code info.
Class
Drugs
Desoximetasone
active
pharmaceutical
ingredient
packaged in
varying grams or
kg in bags or
drums
All lots
Class II
repackaged
and distributed
between
01/05/12 to
02/12/15
Drugs
Dexamethasone
Base active
pharmaceutical
ingredient
packaged in
varying grams or
kg in bags or
drums
All lots
Class II
repackaged
and distributed
between
01/05/12 to
02/12/15
Drugs
Dexamethasone
Sodium
Phosphate active
pharmaceutical
ingredient
packaged in
varying grams or
kg in bags or
drums
All lots
Class II
repackaged
and distributed
between
01/05/12 to
02/12/15
Copyright© PerformRx, LLC 2015 All Rights Reserved
Reason for Recall
with penicillin.
Penicillin Cross
Contamination: All lots of
all products repackaged
and distributed between
01/05/12 and 02/12/15
are being recalled
because they were
repackaged in a facility
with penicillin products
without adequate
separation which could
introduce the potential
for cross contamination
with penicillin.
Penicillin Cross
Contamination: All lots of
all products repackaged
and distributed between
01/05/12 and 02/12/15
are being recalled
because they were
repackaged in a facility
with penicillin products
without adequate
separation which could
introduce the potential
for cross contamination
with penicillin.
Penicillin Cross
Contamination: All lots of
all products repackaged
and distributed between
01/05/12 and 02/12/15
are being recalled
because they were
repackaged in a facility
with penicillin products
without adequate
separation which could
introduce the potential
Recalling firm
Attix
Pharmaceutic
als
Attix
Pharmaceutic
als
Attix
Pharmaceutic
als
64
Product
Type
Product
Description
Code info.
Class
Drugs
Dexchlorphenira
mine Maleate
active
pharmaceutical
ingredient
packaged in
varying grams or
kg in bags or
drums
All lots
Class II
repackaged
and distributed
between
01/05/12 to
02/12/15
Drugs
Dexmedetomidin
e HCI active
pharmaceutical
ingredient
packaged in
varying grams or
kg in bags or
drums
All lots
Class II
repackaged
and distributed
between
01/05/12 to
02/12/15
Drugs
Dexrazoxane
active
pharmaceutical
ingredient
packaged in
varying grams or
kg in bags or
drums
All lots
Class II
repackaged
and distributed
between
01/05/12 to
02/12/15
Copyright© PerformRx, LLC 2015 All Rights Reserved
Reason for Recall
for cross contamination
with penicillin.
Penicillin Cross
Contamination: All lots of
all products repackaged
and distributed between
01/05/12 and 02/12/15
are being recalled
because they were
repackaged in a facility
with penicillin products
without adequate
separation which could
introduce the potential
for cross contamination
with penicillin.
Penicillin Cross
Contamination: All lots of
all products repackaged
and distributed between
01/05/12 and 02/12/15
are being recalled
because they were
repackaged in a facility
with penicillin products
without adequate
separation which could
introduce the potential
for cross contamination
with penicillin.
Penicillin Cross
Contamination: All lots of
all products repackaged
and distributed between
01/05/12 and 02/12/15
are being recalled
because they were
repackaged in a facility
with penicillin products
without adequate
separation which could
Recalling firm
Attix
Pharmaceutic
als
Attix
Pharmaceutic
als
Attix
Pharmaceutic
als
65
Product
Type
Product
Description
Code info.
Class
Drugs
Dextran-70 active
pharmaceutical
ingredient
packaged in
varying grams or
kg in bags or
drums
All lots
Class II
repackaged
and distributed
between
01/05/12 to
02/12/15
Drugs
Diclofenac
Sodium active
pharmaceutical
ingredient
packaged in
varying grams or
kg in bags or
drums
All lots
Class II
repackaged
and distributed
between
01/05/12 to
02/12/15
Drugs
Digoxin active
pharmaceutical
ingredient
packaged in
varying grams or
kg in bags or
drums
All lots
Class II
repackaged
and distributed
between
01/05/12 to
02/12/15
Copyright© PerformRx, LLC 2015 All Rights Reserved
Reason for Recall
introduce the potential
for cross contamination
with penicillin.
Penicillin Cross
Contamination: All lots of
all products repackaged
and distributed between
01/05/12 and 02/12/15
are being recalled
because they were
repackaged in a facility
with penicillin products
without adequate
separation which could
introduce the potential
for cross contamination
with penicillin.
Penicillin Cross
Contamination: All lots of
all products repackaged
and distributed between
01/05/12 and 02/12/15
are being recalled
because they were
repackaged in a facility
with penicillin products
without adequate
separation which could
introduce the potential
for cross contamination
with penicillin.
Penicillin Cross
Contamination: All lots of
all products repackaged
and distributed between
01/05/12 and 02/12/15
are being recalled
because they were
repackaged in a facility
with penicillin products
without adequate
Recalling firm
Attix
Pharmaceutic
als
Attix
Pharmaceutic
als
Attix
Pharmaceutic
als
66
Product
Type
Product
Description
Code info.
Class
Drugs
Dimethyl
Fumarate active
pharmaceutical
ingredient
packaged in
varying grams or
kg in bags or
drums
All lots
Class II
repackaged
and distributed
between
01/05/12 to
02/12/15
Drugs
Diphemanil
Methylsulfate
active
pharmaceutical
ingredient
packaged in
varying grams or
kg in bags or
drums
All lots
Class II
repackaged
and distributed
between
01/05/12 to
02/12/15
Drugs
Diphenylcyclopro
penone active
pharmaceutical
ingredient
packaged in
varying grams or
kg in bags or
drums
All lots
Class II
repackaged
and distributed
between
01/05/12 to
02/12/15
Copyright© PerformRx, LLC 2015 All Rights Reserved
Reason for Recall
separation which could
introduce the potential
for cross contamination
with penicillin.
Penicillin Cross
Contamination: All lots of
all products repackaged
and distributed between
01/05/12 and 02/12/15
are being recalled
because they were
repackaged in a facility
with penicillin products
without adequate
separation which could
introduce the potential
for cross contamination
with penicillin.
Penicillin Cross
Contamination: All lots of
all products repackaged
and distributed between
01/05/12 and 02/12/15
are being recalled
because they were
repackaged in a facility
with penicillin products
without adequate
separation which could
introduce the potential
for cross contamination
with penicillin.
Penicillin Cross
Contamination: All lots of
all products repackaged
and distributed between
01/05/12 and 02/12/15
are being recalled
because they were
repackaged in a facility
with penicillin products
Recalling firm
Attix
Pharmaceutic
als
Attix
Pharmaceutic
als
Attix
Pharmaceutic
als
67
Product
Type
Product
Description
Code info.
Class
Drugs
Disulfiram active
pharmaceutical
ingredient
packaged in
varying grams or
kg in bags or
drums
All lots
Class II
repackaged
and distributed
between
01/05/12 to
02/12/15
Drugs
Dobutamine
Hydrochloride
active
pharmaceutical
ingredient
packaged in
varying grams or
kg in bags or
drums
All lots
Class II
repackaged
and distributed
between
01/05/12 to
02/12/15
Drugs
Docetaxel
Anhydrous active
pharmaceutical
ingredient
packaged in
varying grams or
kg in bags or
drums
All lots
Class II
repackaged
and distributed
between
01/05/12 to
02/12/15
Copyright© PerformRx, LLC 2015 All Rights Reserved
Reason for Recall
without adequate
separation which could
introduce the potential
for cross contamination
with penicillin.
Penicillin Cross
Contamination: All lots of
all products repackaged
and distributed between
01/05/12 and 02/12/15
are being recalled
because they were
repackaged in a facility
with penicillin products
without adequate
separation which could
introduce the potential
for cross contamination
with penicillin.
Penicillin Cross
Contamination: All lots of
all products repackaged
and distributed between
01/05/12 and 02/12/15
are being recalled
because they were
repackaged in a facility
with penicillin products
without adequate
separation which could
introduce the potential
for cross contamination
with penicillin.
Penicillin Cross
Contamination: All lots of
all products repackaged
and distributed between
01/05/12 and 02/12/15
are being recalled
because they were
repackaged in a facility
Recalling firm
Attix
Pharmaceutic
als
Attix
Pharmaceutic
als
Attix
Pharmaceutic
als
68
Product
Type
Product
Description
Code info.
Class
Drugs
Domperidone
active
pharmaceutical
ingredient
packaged in
varying grams or
kg in bags or
drums
All lots
Class II
repackaged
and distributed
between
01/05/12 to
02/12/15
Drugs
Dopamine HCI
active
pharmaceutical
ingredient
packaged in
varying grams or
kg in bags or
drums
All lots
Class II
repackaged
and distributed
between
01/05/12 to
02/12/15
Drugs
Doxapram HCI
Monohydrate
active
pharmaceutical
ingredient
packaged in
varying grams or
All lots
Class II
repackaged
and distributed
between
01/05/12 to
02/12/15
Copyright© PerformRx, LLC 2015 All Rights Reserved
Reason for Recall
with penicillin products
without adequate
separation which could
introduce the potential
for cross contamination
with penicillin.
Penicillin Cross
Contamination: All lots of
all products repackaged
and distributed between
01/05/12 and 02/12/15
are being recalled
because they were
repackaged in a facility
with penicillin products
without adequate
separation which could
introduce the potential
for cross contamination
with penicillin.
Penicillin Cross
Contamination: All lots of
all products repackaged
and distributed between
01/05/12 and 02/12/15
are being recalled
because they were
repackaged in a facility
with penicillin products
without adequate
separation which could
introduce the potential
for cross contamination
with penicillin.
Penicillin Cross
Contamination: All lots of
all products repackaged
and distributed between
01/05/12 and 02/12/15
are being recalled
because they were
Recalling firm
Attix
Pharmaceutic
als
Attix
Pharmaceutic
als
Attix
Pharmaceutic
als
69
Product
Type
Product
Description
kg in bags or
drums
Code info.
Class
Drugs
Doxorubicin HCI
active
pharmaceutical
ingredient
packaged in
varying grams or
kg in bags or
drums
All lots
Class II
repackaged
and distributed
between
01/05/12 to
02/12/15
Drugs
Doxycycline HCI
active
pharmaceutical
ingredient
packaged in
varying grams or
kg in bags or
drums
All lots
Class II
repackaged
and distributed
between
01/05/12 to
02/12/15
Drugs
Doxycycline
Hyclate active
pharmaceutical
ingredient
packaged in
varying grams or
All lots
Class II
repackaged
and distributed
between
01/05/12 to
02/12/15
Copyright© PerformRx, LLC 2015 All Rights Reserved
Reason for Recall
repackaged in a facility
with penicillin products
without adequate
separation which could
introduce the potential
for cross contamination
with penicillin.
Penicillin Cross
Contamination: All lots of
all products repackaged
and distributed between
01/05/12 and 02/12/15
are being recalled
because they were
repackaged in a facility
with penicillin products
without adequate
separation which could
introduce the potential
for cross contamination
with penicillin.
Penicillin Cross
Contamination: All lots of
all products repackaged
and distributed between
01/05/12 and 02/12/15
are being recalled
because they were
repackaged in a facility
with penicillin products
without adequate
separation which could
introduce the potential
for cross contamination
with penicillin.
Penicillin Cross
Contamination: All lots of
all products repackaged
and distributed between
01/05/12 and 02/12/15
are being recalled
Recalling firm
Attix
Pharmaceutic
als
Attix
Pharmaceutic
als
Attix
Pharmaceutic
als
70
Product
Type
Product
Description
kg in bags or
drums
Code info.
Class
Drugs
Doxycycline
Monohydrate
active
pharmaceutical
ingredient
packaged in
varying grams or
kg in bags or
drums
All lots
Class II
repackaged
and distributed
between
01/05/12 to
02/12/15
Drugs
D-Penicillamine
active
pharmaceutical
ingredient
packaged in
varying grams or
kg in bags or
drums
All lots
Class II
repackaged
and distributed
between
01/05/12 to
02/12/15
Drugs
Droperidol active
pharmaceutical
ingredient
packaged in
varying grams or
All lots
Class II
repackaged
and distributed
between
01/05/12 to
Copyright© PerformRx, LLC 2015 All Rights Reserved
Reason for Recall
because they were
repackaged in a facility
with penicillin products
without adequate
separation which could
introduce the potential
for cross contamination
with penicillin.
Penicillin Cross
Contamination: All lots of
all products repackaged
and distributed between
01/05/12 and 02/12/15
are being recalled
because they were
repackaged in a facility
with penicillin products
without adequate
separation which could
introduce the potential
for cross contamination
with penicillin.
Penicillin Cross
Contamination: All lots of
all products repackaged
and distributed between
01/05/12 and 02/12/15
are being recalled
because they were
repackaged in a facility
with penicillin products
without adequate
separation which could
introduce the potential
for cross contamination
with penicillin.
Penicillin Cross
Contamination: All lots of
all products repackaged
and distributed between
01/05/12 and 02/12/15
Recalling firm
Attix
Pharmaceutic
als
Attix
Pharmaceutic
als
Attix
Pharmaceutic
als
71
Product
Type
Product
Description
kg in bags or
drums
Code info.
Class
Drugs
Duloxetine HCl
active
pharmaceutical
ingredient
packaged in
varying grams or
kg in bags or
drums
All lots
Class II
repackaged
and distributed
between
01/05/12 to
02/12/15
Drugs
EDTA
Dipotassium
Magnesium Salt
Dihydrate active
pharmaceutical
ingredient
packaged in
varying grams or
kg in bags or
drums
All lots
Class II
repackaged
and distributed
between
01/05/12 to
02/12/15
Drugs
Enalapril Maleate
active
pharmaceutical
ingredient
All lots
Class II
repackaged
and distributed
between
02/12/15
Copyright© PerformRx, LLC 2015 All Rights Reserved
Reason for Recall
are being recalled
because they were
repackaged in a facility
with penicillin products
without adequate
separation which could
introduce the potential
for cross contamination
with penicillin.
Penicillin Cross
Contamination: All lots of
all products repackaged
and distributed between
01/05/12 and 02/12/15
are being recalled
because they were
repackaged in a facility
with penicillin products
without adequate
separation which could
introduce the potential
for cross contamination
with penicillin.
Penicillin Cross
Contamination: All lots of
all products repackaged
and distributed between
01/05/12 and 02/12/15
are being recalled
because they were
repackaged in a facility
with penicillin products
without adequate
separation which could
introduce the potential
for cross contamination
with penicillin.
Penicillin Cross
Contamination: All lots of
all products repackaged
and distributed between
Recalling firm
Attix
Pharmaceutic
als
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Pharmaceutic
als
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Pharmaceutic
als
72
Product
Type
Product
Description
packaged in
varying grams or
kg in bags or
drums
Code info.
Class
Drugs
Enzalutamide
active
pharmaceutical
ingredient
packaged in
varying grams or
kg in bags or
drums
All lots
Class II
repackaged
and distributed
between
01/05/12 to
02/12/15
Drugs
Epinephrine
active
pharmaceutical
ingredient
packaged in
varying grams or
kg in bags or
drums
All lots
Class II
repackaged
and distributed
between
01/05/12 to
02/12/15
Drugs
Esomeprazole
Magnesium
Trihydrate active
All lots
Class II
repackaged
and distributed
01/05/12 to
02/12/15
Copyright© PerformRx, LLC 2015 All Rights Reserved
Reason for Recall
01/05/12 and 02/12/15
are being recalled
because they were
repackaged in a facility
with penicillin products
without adequate
separation which could
introduce the potential
for cross contamination
with penicillin.
Penicillin Cross
Contamination: All lots of
all products repackaged
and distributed between
01/05/12 and 02/12/15
are being recalled
because they were
repackaged in a facility
with penicillin products
without adequate
separation which could
introduce the potential
for cross contamination
with penicillin.
Penicillin Cross
Contamination: All lots of
all products repackaged
and distributed between
01/05/12 and 02/12/15
are being recalled
because they were
repackaged in a facility
with penicillin products
without adequate
separation which could
introduce the potential
for cross contamination
with penicillin.
Penicillin Cross
Contamination: All lots of
all products repackaged
Recalling firm
Attix
Pharmaceutic
als
Attix
Pharmaceutic
als
Attix
Pharmaceutic
als
73
Product
Type
Product
Description
pharmaceutical
ingredient
packaged in
varying grams or
kg in bags or
drums
Code info.
Class
Drugs
Estradiol active
pharmaceutical
ingredient
packaged in
varying grams or
kg in bags or
drums
All lots
Class II
repackaged
and distributed
between
01/05/12 to
02/12/15
Drugs
Estradiol
(Micronized)
active
pharmaceutical
ingredient
packaged in
varying grams or
kg in bags or
drums
All lots
Class II
repackaged
and distributed
between
01/05/12 to
02/12/15
Drugs
Estradiol (NonMicronized)
All lots
repackaged
between
01/05/12 to
02/12/15
Class II
Copyright© PerformRx, LLC 2015 All Rights Reserved
Reason for Recall
and distributed between
01/05/12 and 02/12/15
are being recalled
because they were
repackaged in a facility
with penicillin products
without adequate
separation which could
introduce the potential
for cross contamination
with penicillin.
Penicillin Cross
Contamination: All lots of
all products repackaged
and distributed between
01/05/12 and 02/12/15
are being recalled
because they were
repackaged in a facility
with penicillin products
without adequate
separation which could
introduce the potential
for cross contamination
with penicillin.
Penicillin Cross
Contamination: All lots of
all products repackaged
and distributed between
01/05/12 and 02/12/15
are being recalled
because they were
repackaged in a facility
with penicillin products
without adequate
separation which could
introduce the potential
for cross contamination
with penicillin.
Penicillin Cross
Contamination: All lots of
Recalling firm
Attix
Pharmaceutic
als
Attix
Pharmaceutic
als
Attix
Pharmaceutic
74
Product
Type
Product
Description
active
pharmaceutical
ingredient
packaged in
varying grams or
kg in bags or
drums
Code info.
Class
Drugs
Estradiol
Cypionate active
pharmaceutical
ingredient
packaged in
varying grams or
kg in bags or
drums
All lots
Class II
repackaged
and distributed
between
01/05/12 to
02/12/15
Drugs
Estriol active
pharmaceutical
ingredient
packaged in
varying grams or
kg in bags or
drums
All lots
Class II
repackaged
and distributed
between
01/05/12 to
02/12/15
Drugs
Estriol (Ultra-
All lots
and distributed
between
01/05/12 to
02/12/15
Class II
Copyright© PerformRx, LLC 2015 All Rights Reserved
Reason for Recall
Recalling firm
all products repackaged
and distributed between
01/05/12 and 02/12/15
are being recalled
because they were
repackaged in a facility
with penicillin products
without adequate
separation which could
introduce the potential
for cross contamination
with penicillin.
Penicillin Cross
Contamination: All lots of
all products repackaged
and distributed between
01/05/12 and 02/12/15
are being recalled
because they were
repackaged in a facility
with penicillin products
without adequate
separation which could
introduce the potential
for cross contamination
with penicillin.
Penicillin Cross
Contamination: All lots of
all products repackaged
and distributed between
01/05/12 and 02/12/15
are being recalled
because they were
repackaged in a facility
with penicillin products
without adequate
separation which could
introduce the potential
for cross contamination
with penicillin.
Penicillin Cross
als
Attix
Pharmaceutic
als
Attix
Pharmaceutic
als
Attix
75
Product
Type
Product
Description
Micronized)
active
pharmaceutical
ingredient
packaged in
varying grams or
kg in bags or
drums
Code info.
Class
Drugs
Estrone active
pharmaceutical
ingredient
packaged in
varying grams or
kg in bags or
drums
All lots
Class II
repackaged
and distributed
between
01/05/12 to
02/12/15
Drugs
Etamsylate active
pharmaceutical
ingredient
packaged in
varying grams or
kg in bags or
drums
All lots
Class II
repackaged
and distributed
between
01/05/12 to
02/12/15
repackaged
and distributed
between
01/05/12 to
02/12/15
Copyright© PerformRx, LLC 2015 All Rights Reserved
Reason for Recall
Recalling firm
Contamination: All lots of
all products repackaged
and distributed between
01/05/12 and 02/12/15
are being recalled
because they were
repackaged in a facility
with penicillin products
without adequate
separation which could
introduce the potential
for cross contamination
with penicillin.
Penicillin Cross
Contamination: All lots of
all products repackaged
and distributed between
01/05/12 and 02/12/15
are being recalled
because they were
repackaged in a facility
with penicillin products
without adequate
separation which could
introduce the potential
for cross contamination
with penicillin.
Penicillin Cross
Contamination: All lots of
all products repackaged
and distributed between
01/05/12 and 02/12/15
are being recalled
because they were
repackaged in a facility
with penicillin products
without adequate
separation which could
introduce the potential
for cross contamination
with penicillin.
Pharmaceutic
als
Attix
Pharmaceutic
als
Attix
Pharmaceutic
als
76
Product
Type
Drugs
Product
Description
Ethambutol HCl
active
pharmaceutical
ingredient
packaged in
varying grams or
kg in bags or
drums
Code info.
Class
Drugs
Ethinyl Estradiol
active
pharmaceutical
ingredient
packaged in
varying grams or
kg in bags or
drums
All lots
Class II
repackaged
and distributed
between
01/05/12 to
02/12/15
Drugs
Ethopropazine
HCI active
pharmaceutical
ingredient
packaged in
varying grams or
kg in bags or
drums
All lots
Class II
repackaged
and distributed
between
01/05/12 to
02/12/15
All lots
Class II
repackaged
and distributed
between
01/05/12 to
02/12/15
Copyright© PerformRx, LLC 2015 All Rights Reserved
Reason for Recall
Recalling firm
Penicillin Cross
Contamination: All lots of
all products repackaged
and distributed between
01/05/12 and 02/12/15
are being recalled
because they were
repackaged in a facility
with penicillin products
without adequate
separation which could
introduce the potential
for cross contamination
with penicillin.
Penicillin Cross
Contamination: All lots of
all products repackaged
and distributed between
01/05/12 and 02/12/15
are being recalled
because they were
repackaged in a facility
with penicillin products
without adequate
separation which could
introduce the potential
for cross contamination
with penicillin.
Penicillin Cross
Contamination: All lots of
all products repackaged
and distributed between
01/05/12 and 02/12/15
are being recalled
because they were
repackaged in a facility
with penicillin products
without adequate
separation which could
introduce the potential
for cross contamination
Attix
Pharmaceutic
als
Attix
Pharmaceutic
als
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Pharmaceutic
als
77
Product
Type
Product
Description
Code info.
Class
Drugs
Etidronate
Disodium active
pharmaceutical
ingredient
packaged in
varying grams or
kg in bags or
drums
All lots
Class II
repackaged
and distributed
between
01/05/12 to
02/12/15
Drugs
Etodolac active
pharmaceutical
ingredient
packaged in
varying grams or
kg in bags or
drums
All lots
Class II
repackaged
and distributed
between
01/05/12 to
02/12/15
Drugs
Etomidate active
pharmaceutical
ingredient
packaged in
varying grams or
kg in bags or
drums
All lots
Class II
repackaged
and distributed
between
01/05/12 to
02/12/15
Copyright© PerformRx, LLC 2015 All Rights Reserved
Reason for Recall
with penicillin.
Penicillin Cross
Contamination: All lots of
all products repackaged
and distributed between
01/05/12 and 02/12/15
are being recalled
because they were
repackaged in a facility
with penicillin products
without adequate
separation which could
introduce the potential
for cross contamination
with penicillin.
Penicillin Cross
Contamination: All lots of
all products repackaged
and distributed between
01/05/12 and 02/12/15
are being recalled
because they were
repackaged in a facility
with penicillin products
without adequate
separation which could
introduce the potential
for cross contamination
with penicillin.
Penicillin Cross
Contamination: All lots of
all products repackaged
and distributed between
01/05/12 and 02/12/15
are being recalled
because they were
repackaged in a facility
with penicillin products
without adequate
separation which could
introduce the potential
Recalling firm
Attix
Pharmaceutic
als
Attix
Pharmaceutic
als
Attix
Pharmaceutic
als
78
Product
Type
Product
Description
Code info.
Class
Drugs
Etoposide active
pharmaceutical
ingredient
packaged in
varying grams or
kg in bags or
drums
All lots
Class II
repackaged
and distributed
between
01/05/12 to
02/12/15
Drugs
Etravirine active
pharmaceutical
ingredient
packaged in
varying grams or
kg in bags or
drums
All lots
Class II
repackaged
and distributed
between
01/05/12 to
02/12/15
Drugs
Everolimus active
pharmaceutical
ingredient
packaged in
varying grams or
kg in bags or
drums
All lots
Class II
repackaged
and distributed
between
01/05/12 to
02/12/15
Copyright© PerformRx, LLC 2015 All Rights Reserved
Reason for Recall
for cross contamination
with penicillin.
Penicillin Cross
Contamination: All lots of
all products repackaged
and distributed between
01/05/12 and 02/12/15
are being recalled
because they were
repackaged in a facility
with penicillin products
without adequate
separation which could
introduce the potential
for cross contamination
with penicillin.
Penicillin Cross
Contamination: All lots of
all products repackaged
and distributed between
01/05/12 and 02/12/15
are being recalled
because they were
repackaged in a facility
with penicillin products
without adequate
separation which could
introduce the potential
for cross contamination
with penicillin.
Penicillin Cross
Contamination: All lots of
all products repackaged
and distributed between
01/05/12 and 02/12/15
are being recalled
because they were
repackaged in a facility
with penicillin products
without adequate
separation which could
Recalling firm
Attix
Pharmaceutic
als
Attix
Pharmaceutic
als
Attix
Pharmaceutic
als
79
Product
Type
Product
Description
Code info.
Class
Drugs
Exemestane
active
pharmaceutical
ingredient
packaged in
varying grams or
kg in bags or
drums
All lots
Class II
repackaged
and distributed
between
01/05/12 to
02/12/15
Drugs
Ezetimibe active
pharmaceutical
ingredient
packaged in
varying grams or
kg in bags or
drums
All lots
Class II
repackaged
and distributed
between
01/05/12 to
02/12/15
Drugs
Famciclovir active
pharmaceutical
ingredient
packaged in
varying grams or
kg in bags or
drums
All lots
Class II
repackaged
and distributed
between
01/05/12 to
02/12/15
Copyright© PerformRx, LLC 2015 All Rights Reserved
Reason for Recall
introduce the potential
for cross contamination
with penicillin.
Penicillin Cross
Contamination: All lots of
all products repackaged
and distributed between
01/05/12 and 02/12/15
are being recalled
because they were
repackaged in a facility
with penicillin products
without adequate
separation which could
introduce the potential
for cross contamination
with penicillin.
Penicillin Cross
Contamination: All lots of
all products repackaged
and distributed between
01/05/12 and 02/12/15
are being recalled
because they were
repackaged in a facility
with penicillin products
without adequate
separation which could
introduce the potential
for cross contamination
with penicillin.
Penicillin Cross
Contamination: All lots of
all products repackaged
and distributed between
01/05/12 and 02/12/15
are being recalled
because they were
repackaged in a facility
with penicillin products
without adequate
Recalling firm
Attix
Pharmaceutic
als
Attix
Pharmaceutic
als
Attix
Pharmaceutic
als
80
Product
Type
Product
Description
Code info.
Class
Drugs
Famotidine active
pharmaceutical
ingredient
packaged in
varying grams or
kg in bags or
drums
All lots
Class II
repackaged
and distributed
between
01/05/12 to
02/12/15
Drugs
Felbamate active
pharmaceutical
ingredient
packaged in
varying grams or
kg in bags or
drums
All lots
Class II
repackaged
and distributed
between
01/05/12 to
02/12/15
Drugs
Finasteride active
pharmaceutical
ingredient
packaged in
varying grams or
kg in bags or
drums
All lots
Class II
repackaged
and distributed
between
01/05/12 to
02/12/15
Copyright© PerformRx, LLC 2015 All Rights Reserved
Reason for Recall
separation which could
introduce the potential
for cross contamination
with penicillin.
Penicillin Cross
Contamination: All lots of
all products repackaged
and distributed between
01/05/12 and 02/12/15
are being recalled
because they were
repackaged in a facility
with penicillin products
without adequate
separation which could
introduce the potential
for cross contamination
with penicillin.
Penicillin Cross
Contamination: All lots of
all products repackaged
and distributed between
01/05/12 and 02/12/15
are being recalled
because they were
repackaged in a facility
with penicillin products
without adequate
separation which could
introduce the potential
for cross contamination
with penicillin.
Penicillin Cross
Contamination: All lots of
all products repackaged
and distributed between
01/05/12 and 02/12/15
are being recalled
because they were
repackaged in a facility
with penicillin products
Recalling firm
Attix
Pharmaceutic
als
Attix
Pharmaceutic
als
Attix
Pharmaceutic
als
81
Product
Type
Product
Description
Code info.
Class
Drugs
Flibanserin active
pharmaceutical
ingredient
packaged in
varying grams or
kg in bags or
drums
All lots
Class II
repackaged
and distributed
between
01/05/12 to
02/12/15
Drugs
Floxuridine active
pharmaceutical
ingredient
packaged in
varying grams or
kg in bags or
drums
All lots
Class II
repackaged
and distributed
between
01/05/12 to
02/12/15
Drugs
Fluconazole
active
pharmaceutical
ingredient
packaged in
varying grams or
kg in bags or
drums
All lots
Class II
repackaged
and distributed
between
01/05/12 to
02/12/15
Copyright© PerformRx, LLC 2015 All Rights Reserved
Reason for Recall
without adequate
separation which could
introduce the potential
for cross contamination
with penicillin.
Penicillin Cross
Contamination: All lots of
all products repackaged
and distributed between
01/05/12 and 02/12/15
are being recalled
because they were
repackaged in a facility
with penicillin products
without adequate
separation which could
introduce the potential
for cross contamination
with penicillin.
Penicillin Cross
Contamination: All lots of
all products repackaged
and distributed between
01/05/12 and 02/12/15
are being recalled
because they were
repackaged in a facility
with penicillin products
without adequate
separation which could
introduce the potential
for cross contamination
with penicillin.
Penicillin Cross
Contamination: All lots of
all products repackaged
and distributed between
01/05/12 and 02/12/15
are being recalled
because they were
repackaged in a facility
Recalling firm
Attix
Pharmaceutic
als
Attix
Pharmaceutic
als
Attix
Pharmaceutic
als
82
Product
Type
Product
Description
Code info.
Class
Drugs
Flucytosine active
pharmaceutical
ingredient
packaged in
varying grams or
kg in bags or
drums
All lots
Class II
repackaged
and distributed
between
01/05/12 to
02/12/15
Drugs
Flumazenil active
pharmaceutical
ingredient
packaged in
varying grams or
kg in bags or
drums
All lots
Class II
repackaged
and distributed
between
01/05/12 to
02/12/15
Drugs
Flumethasone
active
pharmaceutical
ingredient
packaged in
varying grams or
kg in bags or
All lots
Class II
repackaged
and distributed
between
01/05/12 to
02/12/15
Copyright© PerformRx, LLC 2015 All Rights Reserved
Reason for Recall
with penicillin products
without adequate
separation which could
introduce the potential
for cross contamination
with penicillin.
Penicillin Cross
Contamination: All lots of
all products repackaged
and distributed between
01/05/12 and 02/12/15
are being recalled
because they were
repackaged in a facility
with penicillin products
without adequate
separation which could
introduce the potential
for cross contamination
with penicillin.
Penicillin Cross
Contamination: All lots of
all products repackaged
and distributed between
01/05/12 and 02/12/15
are being recalled
because they were
repackaged in a facility
with penicillin products
without adequate
separation which could
introduce the potential
for cross contamination
with penicillin.
Penicillin Cross
Contamination: All lots of
all products repackaged
and distributed between
01/05/12 and 02/12/15
are being recalled
because they were
Recalling firm
Attix
Pharmaceutic
als
Attix
Pharmaceutic
als
Attix
Pharmaceutic
als
83
Product
Type
Product
Description
drums
Code info.
Class
Drugs
Flunarizine HCl
active
pharmaceutical
ingredient
packaged in
varying grams or
kg in bags or
drums
All lots
Class II
repackaged
and distributed
between
01/05/12 to
02/12/15
Drugs
Fluorescein
Sodium active
pharmaceutical
ingredient
packaged in
varying grams or
kg in bags or
drums
All lots
Class II
repackaged
and distributed
between
01/05/12 to
02/12/15
Drugs
Fluorexon active
pharmaceutical
ingredient
packaged in
varying grams or
kg in bags or
All lots
Class II
repackaged
and distributed
between
01/05/12 to
02/12/15
Copyright© PerformRx, LLC 2015 All Rights Reserved
Reason for Recall
repackaged in a facility
with penicillin products
without adequate
separation which could
introduce the potential
for cross contamination
with penicillin.
Penicillin Cross
Contamination: All lots of
all products repackaged
and distributed between
01/05/12 and 02/12/15
are being recalled
because they were
repackaged in a facility
with penicillin products
without adequate
separation which could
introduce the potential
for cross contamination
with penicillin.
Penicillin Cross
Contamination: All lots of
all products repackaged
and distributed between
01/05/12 and 02/12/15
are being recalled
because they were
repackaged in a facility
with penicillin products
without adequate
separation which could
introduce the potential
for cross contamination
with penicillin.
Penicillin Cross
Contamination: All lots of
all products repackaged
and distributed between
01/05/12 and 02/12/15
are being recalled
Recalling firm
Attix
Pharmaceutic
als
Attix
Pharmaceutic
als
Attix
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als
84
Product
Type
Product
Description
drums
Code info.
Class
Drugs
Fluoxetine
Hydrochloride
active
pharmaceutical
ingredient
packaged in
varying grams or
kg in bags or
drums
All lots
Class II
repackaged
and distributed
between
01/05/12 to
02/12/15
Drugs
Fluphenazine
Decanoate active
pharmaceutical
ingredient
packaged in
varying grams or
kg in bags or
drums
All lots
Class II
repackaged
and distributed
between
01/05/12 to
02/12/15
Drugs
Fluphenazine HCl
active
pharmaceutical
ingredient
packaged in
All lots
Class II
repackaged
and distributed
between
01/05/12 to
Copyright© PerformRx, LLC 2015 All Rights Reserved
Reason for Recall
because they were
repackaged in a facility
with penicillin products
without adequate
separation which could
introduce the potential
for cross contamination
with penicillin.
Penicillin Cross
Contamination: All lots of
all products repackaged
and distributed between
01/05/12 and 02/12/15
are being recalled
because they were
repackaged in a facility
with penicillin products
without adequate
separation which could
introduce the potential
for cross contamination
with penicillin.
Penicillin Cross
Contamination: All lots of
all products repackaged
and distributed between
01/05/12 and 02/12/15
are being recalled
because they were
repackaged in a facility
with penicillin products
without adequate
separation which could
introduce the potential
for cross contamination
with penicillin.
Penicillin Cross
Contamination: All lots of
all products repackaged
and distributed between
01/05/12 and 02/12/15
Recalling firm
Attix
Pharmaceutic
als
Attix
Pharmaceutic
als
Attix
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als
85
Product
Type
Product
Description
varying grams or
kg in bags or
drums
Code info.
Class
Drugs
Fluprostenol
active
pharmaceutical
ingredient
packaged in
varying grams or
kg in bags or
drums
All lots
Class II
repackaged
and distributed
between
01/05/12 to
02/12/15
Drugs
Flurbiprofen
active
pharmaceutical
ingredient
packaged in
varying grams or
kg in bags or
drums
All lots
Class II
repackaged
and distributed
between
01/05/12 to
02/12/15
Drugs
Flutamide active
pharmaceutical
ingredient
packaged in
All lots
Class II
repackaged
and distributed
between
02/12/15
Copyright© PerformRx, LLC 2015 All Rights Reserved
Reason for Recall
are being recalled
because they were
repackaged in a facility
with penicillin products
without adequate
separation which could
introduce the potential
for cross contamination
with penicillin.
Penicillin Cross
Contamination: All lots of
all products repackaged
and distributed between
01/05/12 and 02/12/15
are being recalled
because they were
repackaged in a facility
with penicillin products
without adequate
separation which could
introduce the potential
for cross contamination
with penicillin.
Penicillin Cross
Contamination: All lots of
all products repackaged
and distributed between
01/05/12 and 02/12/15
are being recalled
because they were
repackaged in a facility
with penicillin products
without adequate
separation which could
introduce the potential
for cross contamination
with penicillin.
Penicillin Cross
Contamination: All lots of
all products repackaged
and distributed between
Recalling firm
Attix
Pharmaceutic
als
Attix
Pharmaceutic
als
Attix
Pharmaceutic
als
86
Product
Type
Product
Description
varying grams or
kg in bags or
drums
Code info.
Class
Drugs
Fluticasone
Propionate active
pharmaceutical
ingredient
packaged in
varying grams or
kg in bags or
drums
All lots
Class II
repackaged
and distributed
between
01/05/12 to
02/12/15
Drugs
Formestane
active
pharmaceutical
ingredient
packaged in
varying grams or
kg in bags or
drums
All lots
Class II
repackaged
and distributed
between
01/05/12 to
02/12/15
Drugs
Formoterol
Fumarate
Dihydrate active
All lots
Class II
repackaged
and distributed
01/05/12 to
02/12/15
Copyright© PerformRx, LLC 2015 All Rights Reserved
Reason for Recall
01/05/12 and 02/12/15
are being recalled
because they were
repackaged in a facility
with penicillin products
without adequate
separation which could
introduce the potential
for cross contamination
with penicillin.
Penicillin Cross
Contamination: All lots of
all products repackaged
and distributed between
01/05/12 and 02/12/15
are being recalled
because they were
repackaged in a facility
with penicillin products
without adequate
separation which could
introduce the potential
for cross contamination
with penicillin.
Penicillin Cross
Contamination: All lots of
all products repackaged
and distributed between
01/05/12 and 02/12/15
are being recalled
because they were
repackaged in a facility
with penicillin products
without adequate
separation which could
introduce the potential
for cross contamination
with penicillin.
Penicillin Cross
Contamination: All lots of
all products repackaged
Recalling firm
Attix
Pharmaceutic
als
Attix
Pharmaceutic
als
Attix
Pharmaceutic
als
87
Product
Type
Product
Description
pharmaceutical
ingredient
packaged in
varying grams or
kg in bags or
drums
Code info.
Class
Drugs
Fulvestrant active
pharmaceutical
ingredient
packaged in
varying grams or
kg in bags or
drums
All lots
Class II
repackaged
and distributed
between
01/05/12 to
02/12/15
Drugs
Furazolidine
active
pharmaceutical
ingredient
packaged in
varying grams or
kg in bags or
drums
All lots
Class II
repackaged
and distributed
between
01/05/12 to
02/12/15
Drugs
Furosemide
active
All lots
repackaged
between
01/05/12 to
02/12/15
Class II
Copyright© PerformRx, LLC 2015 All Rights Reserved
Reason for Recall
and distributed between
01/05/12 and 02/12/15
are being recalled
because they were
repackaged in a facility
with penicillin products
without adequate
separation which could
introduce the potential
for cross contamination
with penicillin.
Penicillin Cross
Contamination: All lots of
all products repackaged
and distributed between
01/05/12 and 02/12/15
are being recalled
because they were
repackaged in a facility
with penicillin products
without adequate
separation which could
introduce the potential
for cross contamination
with penicillin.
Penicillin Cross
Contamination: All lots of
all products repackaged
and distributed between
01/05/12 and 02/12/15
are being recalled
because they were
repackaged in a facility
with penicillin products
without adequate
separation which could
introduce the potential
for cross contamination
with penicillin.
Penicillin Cross
Contamination: All lots of
Recalling firm
Attix
Pharmaceutic
als
Attix
Pharmaceutic
als
Attix
Pharmaceutic
88
Product
Type
Product
Description
pharmaceutical
ingredient
packaged in
varying grams or
kg in bags or
drums
Code info.
Class
Drugs
Gabapentin
active
pharmaceutical
ingredient
packaged in
varying grams or
kg in bags or
drums
All lots
Class II
repackaged
and distributed
between
01/05/12 to
02/12/15
Drugs
Gatifloxacin
active
pharmaceutical
ingredient
packaged in
varying grams or
kg in bags or
drums
All lots
Class II
repackaged
and distributed
between
01/05/12 to
02/12/15
Drugs
Gefitinib active
All lots
and distributed
between
01/05/12 to
02/12/15
Class II
Copyright© PerformRx, LLC 2015 All Rights Reserved
Reason for Recall
Recalling firm
all products repackaged
and distributed between
01/05/12 and 02/12/15
are being recalled
because they were
repackaged in a facility
with penicillin products
without adequate
separation which could
introduce the potential
for cross contamination
with penicillin.
Penicillin Cross
Contamination: All lots of
all products repackaged
and distributed between
01/05/12 and 02/12/15
are being recalled
because they were
repackaged in a facility
with penicillin products
without adequate
separation which could
introduce the potential
for cross contamination
with penicillin.
Penicillin Cross
Contamination: All lots of
all products repackaged
and distributed between
01/05/12 and 02/12/15
are being recalled
because they were
repackaged in a facility
with penicillin products
without adequate
separation which could
introduce the potential
for cross contamination
with penicillin.
Penicillin Cross
als
Attix
Pharmaceutic
als
Attix
Pharmaceutic
als
Attix
89
Product
Type
Product
Description
pharmaceutical
ingredient
packaged in
varying grams or
kg in bags or
drums
Code info.
Class
Drugs
Gemfibrozil
active
pharmaceutical
ingredient
packaged in
varying grams or
kg in bags or
drums
All lots
Class II
repackaged
and distributed
between
01/05/12 to
02/12/15
Drugs
Glipizide active
pharmaceutical
ingredient
packaged in
varying grams or
kg in bags or
drums
All lots
Class II
repackaged
and distributed
between
01/05/12 to
02/12/15
repackaged
and distributed
between
01/05/12 to
02/12/15
Copyright© PerformRx, LLC 2015 All Rights Reserved
Reason for Recall
Recalling firm
Contamination: All lots of
all products repackaged
and distributed between
01/05/12 and 02/12/15
are being recalled
because they were
repackaged in a facility
with penicillin products
without adequate
separation which could
introduce the potential
for cross contamination
with penicillin.
Penicillin Cross
Contamination: All lots of
all products repackaged
and distributed between
01/05/12 and 02/12/15
are being recalled
because they were
repackaged in a facility
with penicillin products
without adequate
separation which could
introduce the potential
for cross contamination
with penicillin.
Penicillin Cross
Contamination: All lots of
all products repackaged
and distributed between
01/05/12 and 02/12/15
are being recalled
because they were
repackaged in a facility
with penicillin products
without adequate
separation which could
introduce the potential
for cross contamination
with penicillin.
Pharmaceutic
als
Attix
Pharmaceutic
als
Attix
Pharmaceutic
als
90
Product
Type
Drugs
Product
Description
Guanabenz
Acetate active
pharmaceutical
ingredient
packaged in
varying grams or
kg in bags or
drums
Code info.
Class
Drugs
Halobetasol
Propionate active
pharmaceutical
ingredient
packaged in
varying grams or
kg in bags or
drums
All lots
Class II
repackaged
and distributed
between
01/05/12 to
02/12/15
Drugs
Heparin Sodium
active
pharmaceutical
ingredient
packaged in
varying grams or
kg in bags or
drums
All lots
Class II
repackaged
and distributed
between
01/05/12 to
02/12/15
All lots
Class II
repackaged
and distributed
between
01/05/12 to
02/12/15
Copyright© PerformRx, LLC 2015 All Rights Reserved
Reason for Recall
Recalling firm
Penicillin Cross
Contamination: All lots of
all products repackaged
and distributed between
01/05/12 and 02/12/15
are being recalled
because they were
repackaged in a facility
with penicillin products
without adequate
separation which could
introduce the potential
for cross contamination
with penicillin.
Penicillin Cross
Contamination: All lots of
all products repackaged
and distributed between
01/05/12 and 02/12/15
are being recalled
because they were
repackaged in a facility
with penicillin products
without adequate
separation which could
introduce the potential
for cross contamination
with penicillin.
Penicillin Cross
Contamination: All lots of
all products repackaged
and distributed between
01/05/12 and 02/12/15
are being recalled
because they were
repackaged in a facility
with penicillin products
without adequate
separation which could
introduce the potential
for cross contamination
Attix
Pharmaceutic
als
Attix
Pharmaceutic
als
Attix
Pharmaceutic
als
91
Product
Type
Product
Description
Code info.
Class
Drugs
Heptaminol
Hydrochloride
active
pharmaceutical
ingredient
packaged in
varying grams or
kg in bags or
drums
All lots
Class II
repackaged
and distributed
between
01/05/12 to
02/12/15
Drugs
Histamine
Diphosphate
active
pharmaceutical
ingredient
packaged in
varying grams or
kg in bags or
drums
All lots
Class II
repackaged
and distributed
between
01/05/12 to
02/12/15
Drugs
Histamine
Phosphate active
pharmaceutical
ingredient
packaged in
varying grams or
kg in bags or
drums
All lots
Class II
repackaged
and distributed
between
01/05/12 to
02/12/15
Copyright© PerformRx, LLC 2015 All Rights Reserved
Reason for Recall
with penicillin.
Penicillin Cross
Contamination: All lots of
all products repackaged
and distributed between
01/05/12 and 02/12/15
are being recalled
because they were
repackaged in a facility
with penicillin products
without adequate
separation which could
introduce the potential
for cross contamination
with penicillin.
Penicillin Cross
Contamination: All lots of
all products repackaged
and distributed between
01/05/12 and 02/12/15
are being recalled
because they were
repackaged in a facility
with penicillin products
without adequate
separation which could
introduce the potential
for cross contamination
with penicillin.
Penicillin Cross
Contamination: All lots of
all products repackaged
and distributed between
01/05/12 and 02/12/15
are being recalled
because they were
repackaged in a facility
with penicillin products
without adequate
separation which could
introduce the potential
Recalling firm
Attix
Pharmaceutic
als
Attix
Pharmaceutic
als
Attix
Pharmaceutic
als
92
Product
Type
Product
Description
Code info.
Class
Drugs
Homatropine
Methylbromide
active
pharmaceutical
ingredient
packaged in
varying grams or
kg in bags or
drums
All lots
Class II
repackaged
and distributed
between
01/05/12 to
02/12/15
Drugs
Hyaluronic Acid
Sodium Salt
(Injection Grade)
active
pharmaceutical
ingredient
packaged in
varying grams or
kg in bags or
drums
All lots
Class II
repackaged
and distributed
between
01/05/12 to
02/12/15
Drugs
Hyaluronic Acid
Sodium Salt
(Ophthalmic
Grade) active
pharmaceutical
ingredient
packaged in
varying grams or
kg in bags or
drums
All lots
Class II
repackaged
and distributed
between
01/05/12 to
02/12/15
Copyright© PerformRx, LLC 2015 All Rights Reserved
Reason for Recall
for cross contamination
with penicillin.
Penicillin Cross
Contamination: All lots of
all products repackaged
and distributed between
01/05/12 and 02/12/15
are being recalled
because they were
repackaged in a facility
with penicillin products
without adequate
separation which could
introduce the potential
for cross contamination
with penicillin.
Penicillin Cross
Contamination: All lots of
all products repackaged
and distributed between
01/05/12 and 02/12/15
are being recalled
because they were
repackaged in a facility
with penicillin products
without adequate
separation which could
introduce the potential
for cross contamination
with penicillin.
Penicillin Cross
Contamination: All lots of
all products repackaged
and distributed between
01/05/12 and 02/12/15
are being recalled
because they were
repackaged in a facility
with penicillin products
without adequate
separation which could
Recalling firm
Attix
Pharmaceutic
als
Attix
Pharmaceutic
als
Attix
Pharmaceutic
als
93
Product
Type
Product
Description
Code info.
Class
Drugs
Hyaluronic Acid
Sodium Salt
(Pharma Grade)
active
pharmaceutical
ingredient
packaged in
varying grams or
kg in bags or
drums
All lots
Class II
repackaged
and distributed
between
01/05/12 to
02/12/15
Drugs
Hydralazine HCl
active
pharmaceutical
ingredient
packaged in
varying grams or
kg in bags or
drums
All lots
Class II
repackaged
and distributed
between
01/05/12 to
02/12/15
Drugs
Hydrochlorothiazi
de active
pharmaceutical
ingredient
packaged in
varying grams or
kg in bags or
drums
All lots
Class II
repackaged
and distributed
between
01/05/12 to
02/12/15
Copyright© PerformRx, LLC 2015 All Rights Reserved
Reason for Recall
introduce the potential
for cross contamination
with penicillin.
Penicillin Cross
Contamination: All lots of
all products repackaged
and distributed between
01/05/12 and 02/12/15
are being recalled
because they were
repackaged in a facility
with penicillin products
without adequate
separation which could
introduce the potential
for cross contamination
with penicillin.
Penicillin Cross
Contamination: All lots of
all products repackaged
and distributed between
01/05/12 and 02/12/15
are being recalled
because they were
repackaged in a facility
with penicillin products
without adequate
separation which could
introduce the potential
for cross contamination
with penicillin.
Penicillin Cross
Contamination: All lots of
all products repackaged
and distributed between
01/05/12 and 02/12/15
are being recalled
because they were
repackaged in a facility
with penicillin products
without adequate
Recalling firm
Attix
Pharmaceutic
als
Attix
Pharmaceutic
als
Attix
Pharmaceutic
als
94
Product
Type
Product
Description
Code info.
Class
Drugs
Hydrocortisone
active
pharmaceutical
ingredient
packaged in
varying grams or
kg in bags or
drums
All lots
Class II
repackaged
and distributed
between
01/05/12 to
02/12/15
Drugs
Hydrocortisone
base active
pharmaceutical
ingredient
packaged in
varying grams or
kg in bags or
drums
All lots
Class II
repackaged
and distributed
between
01/05/12 to
02/12/15
Drugs
Hydrocortisone
Micronized active
pharmaceutical
ingredient
packaged in
varying grams or
kg in bags or
drums
All lots
Class II
repackaged
and distributed
between
01/05/12 to
02/12/15
Copyright© PerformRx, LLC 2015 All Rights Reserved
Reason for Recall
separation which could
introduce the potential
for cross contamination
with penicillin.
Penicillin Cross
Contamination: All lots of
all products repackaged
and distributed between
01/05/12 and 02/12/15
are being recalled
because they were
repackaged in a facility
with penicillin products
without adequate
separation which could
introduce the potential
for cross contamination
with penicillin.
Penicillin Cross
Contamination: All lots of
all products repackaged
and distributed between
01/05/12 and 02/12/15
are being recalled
because they were
repackaged in a facility
with penicillin products
without adequate
separation which could
introduce the potential
for cross contamination
with penicillin.
Penicillin Cross
Contamination: All lots of
all products repackaged
and distributed between
01/05/12 and 02/12/15
are being recalled
because they were
repackaged in a facility
with penicillin products
Recalling firm
Attix
Pharmaceutic
als
Attix
Pharmaceutic
als
Attix
Pharmaceutic
als
95
Product
Type
Product
Description
Code info.
Class
Drugs
Hydrocortisone
Sodium Succinate
active
pharmaceutical
ingredient
packaged in
varying grams or
kg in bags or
drums
All lots
Class II
repackaged
and distributed
between
01/05/12 to
02/12/15
Drugs
Hydroxocobalami
n active
pharmaceutical
ingredient
packaged in
varying grams or
kg in bags or
drums
All lots
Class II
repackaged
and distributed
between
01/05/12 to
02/12/15
Drugs
Hydroxocobalami
n Acetate active
pharmaceutical
ingredient
packaged in
varying grams or
kg in bags or
drums
All lots
Class II
repackaged
and distributed
between
01/05/12 to
02/12/15
Copyright© PerformRx, LLC 2015 All Rights Reserved
Reason for Recall
without adequate
separation which could
introduce the potential
for cross contamination
with penicillin.
Penicillin Cross
Contamination: All lots of
all products repackaged
and distributed between
01/05/12 and 02/12/15
are being recalled
because they were
repackaged in a facility
with penicillin products
without adequate
separation which could
introduce the potential
for cross contamination
with penicillin.
Penicillin Cross
Contamination: All lots of
all products repackaged
and distributed between
01/05/12 and 02/12/15
are being recalled
because they were
repackaged in a facility
with penicillin products
without adequate
separation which could
introduce the potential
for cross contamination
with penicillin.
Penicillin Cross
Contamination: All lots of
all products repackaged
and distributed between
01/05/12 and 02/12/15
are being recalled
because they were
repackaged in a facility
Recalling firm
Attix
Pharmaceutic
als
Attix
Pharmaceutic
als
Attix
Pharmaceutic
als
96
Product
Type
Product
Description
Code info.
Class
Drugs
Hydroxocobalami
n Base active
pharmaceutical
ingredient
packaged in
varying grams or
kg in bags or
drums
All lots
Class II
repackaged
and distributed
between
01/05/12 to
02/12/15
Drugs
Hydroxocobalami
n HCl active
pharmaceutical
ingredient
packaged in
varying grams or
kg in bags or
drums
All lots
Class II
repackaged
and distributed
between
01/05/12 to
02/12/15
Drugs
Hydroxyprogester
one Caproate
active
pharmaceutical
ingredient
packaged in
varying grams or
All lots
Class II
repackaged
and distributed
between
01/05/12 to
02/12/15
Copyright© PerformRx, LLC 2015 All Rights Reserved
Reason for Recall
with penicillin products
without adequate
separation which could
introduce the potential
for cross contamination
with penicillin.
Penicillin Cross
Contamination: All lots of
all products repackaged
and distributed between
01/05/12 and 02/12/15
are being recalled
because they were
repackaged in a facility
with penicillin products
without adequate
separation which could
introduce the potential
for cross contamination
with penicillin.
Penicillin Cross
Contamination: All lots of
all products repackaged
and distributed between
01/05/12 and 02/12/15
are being recalled
because they were
repackaged in a facility
with penicillin products
without adequate
separation which could
introduce the potential
for cross contamination
with penicillin.
Penicillin Cross
Contamination: All lots of
all products repackaged
and distributed between
01/05/12 and 02/12/15
are being recalled
because they were
Recalling firm
Attix
Pharmaceutic
als
Attix
Pharmaceutic
als
Attix
Pharmaceutic
als
97
Product
Type
Product
Description
kg in bags or
drums
Code info.
Class
Drugs
Hydroxypropyl
Beta Cyclodextrin
active
pharmaceutical
ingredient
packaged in
varying grams or
kg in bags or
drums
All lots
Class II
repackaged
and distributed
between
01/05/12 to
02/12/15
Drugs
Hydroxyurea
active
pharmaceutical
ingredient
packaged in
varying grams or
kg in bags or
drums
All lots
Class II
repackaged
and distributed
between
01/05/12 to
02/12/15
Drugs
Hydroxyzine HCl
active
pharmaceutical
ingredient
packaged in
varying grams or
All lots
Class II
repackaged
and distributed
between
01/05/12 to
02/12/15
Copyright© PerformRx, LLC 2015 All Rights Reserved
Reason for Recall
repackaged in a facility
with penicillin products
without adequate
separation which could
introduce the potential
for cross contamination
with penicillin.
Penicillin Cross
Contamination: All lots of
all products repackaged
and distributed between
01/05/12 and 02/12/15
are being recalled
because they were
repackaged in a facility
with penicillin products
without adequate
separation which could
introduce the potential
for cross contamination
with penicillin.
Penicillin Cross
Contamination: All lots of
all products repackaged
and distributed between
01/05/12 and 02/12/15
are being recalled
because they were
repackaged in a facility
with penicillin products
without adequate
separation which could
introduce the potential
for cross contamination
with penicillin.
Penicillin Cross
Contamination: All lots of
all products repackaged
and distributed between
01/05/12 and 02/12/15
are being recalled
Recalling firm
Attix
Pharmaceutic
als
Attix
Pharmaceutic
als
Attix
Pharmaceutic
als
98
Product
Type
Product
Description
kg in bags or
drums
Code info.
Class
Drugs
Hyoscine
Butylbromide
active
pharmaceutical
ingredient
packaged in
varying grams or
kg in bags or
drums
All lots
Class II
repackaged
and distributed
between
01/05/12 to
02/12/15
Drugs
Hyoscyamine
Sulfate Dihydrate
active
pharmaceutical
ingredient
packaged in
varying grams or
kg in bags or
drums
All lots
Class II
repackaged
and distributed
between
01/05/12 to
02/12/15
Drugs
Ibuprofen active
pharmaceutical
ingredient
packaged in
varying grams or
All lots
Class II
repackaged
and distributed
between
01/05/12 to
Copyright© PerformRx, LLC 2015 All Rights Reserved
Reason for Recall
because they were
repackaged in a facility
with penicillin products
without adequate
separation which could
introduce the potential
for cross contamination
with penicillin.
Penicillin Cross
Contamination: All lots of
all products repackaged
and distributed between
01/05/12 and 02/12/15
are being recalled
because they were
repackaged in a facility
with penicillin products
without adequate
separation which could
introduce the potential
for cross contamination
with penicillin.
Penicillin Cross
Contamination: All lots of
all products repackaged
and distributed between
01/05/12 and 02/12/15
are being recalled
because they were
repackaged in a facility
with penicillin products
without adequate
separation which could
introduce the potential
for cross contamination
with penicillin.
Penicillin Cross
Contamination: All lots of
all products repackaged
and distributed between
01/05/12 and 02/12/15
Recalling firm
Attix
Pharmaceutic
als
Attix
Pharmaceutic
als
Attix
Pharmaceutic
als
99
Product
Type
Product
Description
kg in bags or
drums
Code info.
Class
Drugs
Idebenone active
pharmaceutical
ingredient
packaged in
varying grams or
kg in bags or
drums
All lots
Class II
repackaged
and distributed
between
01/05/12 to
02/12/15
Drugs
Idoxuridine active
pharmaceutical
ingredient
packaged in
varying grams or
kg in bags or
drums
All lots
Class II
repackaged
and distributed
between
01/05/12 to
02/12/15
Drugs
Imatinib Mesylate
active
pharmaceutical
ingredient
All lots
Class II
repackaged
and distributed
between
02/12/15
Copyright© PerformRx, LLC 2015 All Rights Reserved
Reason for Recall
are being recalled
because they were
repackaged in a facility
with penicillin products
without adequate
separation which could
introduce the potential
for cross contamination
with penicillin.
Penicillin Cross
Contamination: All lots of
all products repackaged
and distributed between
01/05/12 and 02/12/15
are being recalled
because they were
repackaged in a facility
with penicillin products
without adequate
separation which could
introduce the potential
for cross contamination
with penicillin.
Penicillin Cross
Contamination: All lots of
all products repackaged
and distributed between
01/05/12 and 02/12/15
are being recalled
because they were
repackaged in a facility
with penicillin products
without adequate
separation which could
introduce the potential
for cross contamination
with penicillin.
Penicillin Cross
Contamination: All lots of
all products repackaged
and distributed between
Recalling firm
Attix
Pharmaceutic
als
Attix
Pharmaceutic
als
Attix
Pharmaceutic
als
100
Product
Type
Product
Description
packaged in
varying grams or
kg in bags or
drums
Code info.
Class
Drugs
Imiquimod active
pharmaceutical
ingredient
packaged in
varying grams or
kg in bags or
drums
All lots
Class II
repackaged
and distributed
between
01/05/12 to
02/12/15
Drugs
Indocyanine
Green active
pharmaceutical
ingredient
packaged in
varying grams or
kg in bags or
drums
All lots
Class II
repackaged
and distributed
between
01/05/12 to
02/12/15
Drugs
Indomethacin
Sodium active
pharmaceutical
All lots
Class II
repackaged
and distributed
01/05/12 to
02/12/15
Copyright© PerformRx, LLC 2015 All Rights Reserved
Reason for Recall
01/05/12 and 02/12/15
are being recalled
because they were
repackaged in a facility
with penicillin products
without adequate
separation which could
introduce the potential
for cross contamination
with penicillin.
Penicillin Cross
Contamination: All lots of
all products repackaged
and distributed between
01/05/12 and 02/12/15
are being recalled
because they were
repackaged in a facility
with penicillin products
without adequate
separation which could
introduce the potential
for cross contamination
with penicillin.
Penicillin Cross
Contamination: All lots of
all products repackaged
and distributed between
01/05/12 and 02/12/15
are being recalled
because they were
repackaged in a facility
with penicillin products
without adequate
separation which could
introduce the potential
for cross contamination
with penicillin.
Penicillin Cross
Contamination: All lots of
all products repackaged
Recalling firm
Attix
Pharmaceutic
als
Attix
Pharmaceutic
als
Attix
Pharmaceutic
als
101
Product
Type
Product
Description
ingredient
packaged in
varying grams or
kg in bags or
drums
Code info.
Class
Drugs
Irbesartan active
pharmaceutical
ingredient
packaged in
varying grams or
kg in bags or
drums
All lots
Class II
repackaged
and distributed
between
01/05/12 to
02/12/15
Drugs
Iron Sucrose or
Ferric Hydroxide
Sucrose Complex
active
pharmaceutical
ingredient
packaged in
varying grams or
kg in bags or
drums
All lots
Class II
repackaged
and distributed
between
01/05/12 to
02/12/15
Drugs
Isoproterenol
Hydrochloride
All lots
repackaged
between
01/05/12 to
02/12/15
Class II
Copyright© PerformRx, LLC 2015 All Rights Reserved
Reason for Recall
and distributed between
01/05/12 and 02/12/15
are being recalled
because they were
repackaged in a facility
with penicillin products
without adequate
separation which could
introduce the potential
for cross contamination
with penicillin.
Penicillin Cross
Contamination: All lots of
all products repackaged
and distributed between
01/05/12 and 02/12/15
are being recalled
because they were
repackaged in a facility
with penicillin products
without adequate
separation which could
introduce the potential
for cross contamination
with penicillin.
Penicillin Cross
Contamination: All lots of
all products repackaged
and distributed between
01/05/12 and 02/12/15
are being recalled
because they were
repackaged in a facility
with penicillin products
without adequate
separation which could
introduce the potential
for cross contamination
with penicillin.
Penicillin Cross
Contamination: All lots of
Recalling firm
Attix
Pharmaceutic
als
Attix
Pharmaceutic
als
Attix
Pharmaceutic
102
Product
Type
Product
Description
active
pharmaceutical
ingredient
packaged in
varying grams or
kg in bags or
drums
Code info.
Class
Drugs
Isosorbide
Dinitrate active
pharmaceutical
ingredient
packaged in
varying grams or
kg in bags or
drums
All lots
Class II
repackaged
and distributed
between
01/05/12 to
02/12/15
Drugs
Isoxsuprine HCl
active
pharmaceutical
ingredient
packaged in
varying grams or
kg in bags or
drums
All lots
Class II
repackaged
and distributed
between
01/05/12 to
02/12/15
Drugs
Itraconazole
All lots
and distributed
between
01/05/12 to
02/12/15
Class II
Copyright© PerformRx, LLC 2015 All Rights Reserved
Reason for Recall
Recalling firm
all products repackaged
and distributed between
01/05/12 and 02/12/15
are being recalled
because they were
repackaged in a facility
with penicillin products
without adequate
separation which could
introduce the potential
for cross contamination
with penicillin.
Penicillin Cross
Contamination: All lots of
all products repackaged
and distributed between
01/05/12 and 02/12/15
are being recalled
because they were
repackaged in a facility
with penicillin products
without adequate
separation which could
introduce the potential
for cross contamination
with penicillin.
Penicillin Cross
Contamination: All lots of
all products repackaged
and distributed between
01/05/12 and 02/12/15
are being recalled
because they were
repackaged in a facility
with penicillin products
without adequate
separation which could
introduce the potential
for cross contamination
with penicillin.
Penicillin Cross
als
Attix
Pharmaceutic
als
Attix
Pharmaceutic
als
Attix
103
Product
Type
Product
Description
active
pharmaceutical
ingredient
packaged in
varying grams or
kg in bags or
drums
Code info.
Class
Drugs
Kanamycin
Sulfate active
pharmaceutical
ingredient
packaged in
varying grams or
kg in bags or
drums
All lots
Class II
repackaged
and distributed
between
01/05/12 to
02/12/15
Drugs
Ketoconazole
active
pharmaceutical
ingredient
packaged in
varying grams or
kg in bags or
drums
All lots
Class II
repackaged
and distributed
between
01/05/12 to
02/12/15
repackaged
and distributed
between
01/05/12 to
02/12/15
Copyright© PerformRx, LLC 2015 All Rights Reserved
Reason for Recall
Recalling firm
Contamination: All lots of
all products repackaged
and distributed between
01/05/12 and 02/12/15
are being recalled
because they were
repackaged in a facility
with penicillin products
without adequate
separation which could
introduce the potential
for cross contamination
with penicillin.
Penicillin Cross
Contamination: All lots of
all products repackaged
and distributed between
01/05/12 and 02/12/15
are being recalled
because they were
repackaged in a facility
with penicillin products
without adequate
separation which could
introduce the potential
for cross contamination
with penicillin.
Penicillin Cross
Contamination: All lots of
all products repackaged
and distributed between
01/05/12 and 02/12/15
are being recalled
because they were
repackaged in a facility
with penicillin products
without adequate
separation which could
introduce the potential
for cross contamination
with penicillin.
Pharmaceutic
als
Attix
Pharmaceutic
als
Attix
Pharmaceutic
als
104
Product
Type
Drugs
Product
Description
Ketoprofen active
pharmaceutical
ingredient
packaged in
varying grams or
kg in bags or
drums
Code info.
Class
Drugs
Ketorolac
Tromethamine
active
pharmaceutical
ingredient
packaged in
varying grams or
kg in bags or
drums
All lots
Class II
repackaged
and distributed
between
01/05/12 to
02/12/15
Drugs
Ketotifen
Fumarate active
pharmaceutical
ingredient
packaged in
varying grams or
kg in bags or
drums
All lots
Class II
repackaged
and distributed
between
01/05/12 to
02/12/15
All lots
Class II
repackaged
and distributed
between
01/05/12 to
02/12/15
Copyright© PerformRx, LLC 2015 All Rights Reserved
Reason for Recall
Recalling firm
Penicillin Cross
Contamination: All lots of
all products repackaged
and distributed between
01/05/12 and 02/12/15
are being recalled
because they were
repackaged in a facility
with penicillin products
without adequate
separation which could
introduce the potential
for cross contamination
with penicillin.
Penicillin Cross
Contamination: All lots of
all products repackaged
and distributed between
01/05/12 and 02/12/15
are being recalled
because they were
repackaged in a facility
with penicillin products
without adequate
separation which could
introduce the potential
for cross contamination
with penicillin.
Penicillin Cross
Contamination: All lots of
all products repackaged
and distributed between
01/05/12 and 02/12/15
are being recalled
because they were
repackaged in a facility
with penicillin products
without adequate
separation which could
introduce the potential
for cross contamination
Attix
Pharmaceutic
als
Attix
Pharmaceutic
als
Attix
Pharmaceutic
als
105
Product
Type
Product
Description
Code info.
Class
Drugs
L-Asparaginase
active
pharmaceutical
ingredient
packaged in
varying grams or
kg in bags or
drums
All lots
Class II
repackaged
and distributed
between
01/05/12 to
02/12/15
Drugs
Labetalol HCl
active
pharmaceutical
ingredient
packaged in
varying grams or
kg in bags or
drums
All lots
Class II
repackaged
and distributed
between
01/05/12 to
02/12/15
Drugs
Lamotrigine
active
pharmaceutical
ingredient
packaged in
varying grams or
kg in bags or
drums
All lots
Class II
repackaged
and distributed
between
01/05/12 to
02/12/15
Copyright© PerformRx, LLC 2015 All Rights Reserved
Reason for Recall
with penicillin.
Penicillin Cross
Contamination: All lots of
all products repackaged
and distributed between
01/05/12 and 02/12/15
are being recalled
because they were
repackaged in a facility
with penicillin products
without adequate
separation which could
introduce the potential
for cross contamination
with penicillin.
Penicillin Cross
Contamination: All lots of
all products repackaged
and distributed between
01/05/12 and 02/12/15
are being recalled
because they were
repackaged in a facility
with penicillin products
without adequate
separation which could
introduce the potential
for cross contamination
with penicillin.
Penicillin Cross
Contamination: All lots of
all products repackaged
and distributed between
01/05/12 and 02/12/15
are being recalled
because they were
repackaged in a facility
with penicillin products
without adequate
separation which could
introduce the potential
Recalling firm
Attix
Pharmaceutic
als
Attix
Pharmaceutic
als
Attix
Pharmaceutic
als
106
Product
Type
Product
Description
Code info.
Class
Drugs
Lansoprazole
active
pharmaceutical
ingredient
packaged in
varying grams or
kg in bags or
drums
All lots
Class II
repackaged
and distributed
between
01/05/12 to
02/12/15
Drugs
Lanthanum
Carbonate active
pharmaceutical
ingredient
packaged in
varying grams or
kg in bags or
drums
All lots
Class II
repackaged
and distributed
between
01/05/12 to
02/12/15
Drugs
Leflunomide
active
pharmaceutical
ingredient
packaged in
varying grams or
kg in bags or
drums
All lots
Class II
repackaged
and distributed
between
01/05/12 to
02/12/15
Copyright© PerformRx, LLC 2015 All Rights Reserved
Reason for Recall
for cross contamination
with penicillin.
Penicillin Cross
Contamination: All lots of
all products repackaged
and distributed between
01/05/12 and 02/12/15
are being recalled
because they were
repackaged in a facility
with penicillin products
without adequate
separation which could
introduce the potential
for cross contamination
with penicillin.
Penicillin Cross
Contamination: All lots of
all products repackaged
and distributed between
01/05/12 and 02/12/15
are being recalled
because they were
repackaged in a facility
with penicillin products
without adequate
separation which could
introduce the potential
for cross contamination
with penicillin.
Penicillin Cross
Contamination: All lots of
all products repackaged
and distributed between
01/05/12 and 02/12/15
are being recalled
because they were
repackaged in a facility
with penicillin products
without adequate
separation which could
Recalling firm
Attix
Pharmaceutic
als
Attix
Pharmaceutic
als
Attix
Pharmaceutic
als
107
Product
Type
Product
Description
Code info.
Class
Drugs
Letrazole active
pharmaceutical
ingredient
packaged in
varying grams or
kg in bags or
drums
All lots
Class II
repackaged
and distributed
between
01/05/12 to
02/12/15
Drugs
Leucovorin
Calcium active
pharmaceutical
ingredient
packaged in
varying grams or
kg in bags or
drums
All lots
Class II
repackaged
and distributed
between
01/05/12 to
02/12/15
Drugs
Levalbuterol HCl
active
pharmaceutical
ingredient
packaged in
varying grams or
kg in bags or
drums
All lots
Class II
repackaged
and distributed
between
01/05/12 to
02/12/15
Copyright© PerformRx, LLC 2015 All Rights Reserved
Reason for Recall
introduce the potential
for cross contamination
with penicillin.
Penicillin Cross
Contamination: All lots of
all products repackaged
and distributed between
01/05/12 and 02/12/15
are being recalled
because they were
repackaged in a facility
with penicillin products
without adequate
separation which could
introduce the potential
for cross contamination
with penicillin.
Penicillin Cross
Contamination: All lots of
all products repackaged
and distributed between
01/05/12 and 02/12/15
are being recalled
because they were
repackaged in a facility
with penicillin products
without adequate
separation which could
introduce the potential
for cross contamination
with penicillin.
Penicillin Cross
Contamination: All lots of
all products repackaged
and distributed between
01/05/12 and 02/12/15
are being recalled
because they were
repackaged in a facility
with penicillin products
without adequate
Recalling firm
Attix
Pharmaceutic
als
Attix
Pharmaceutic
als
Attix
Pharmaceutic
als
108
Product
Type
Product
Description
Code info.
Class
Drugs
Levetiracetam
active
pharmaceutical
ingredient
packaged in
varying grams or
kg in bags or
drums
All lots
Class II
repackaged
and distributed
between
01/05/12 to
02/12/15
Drugs
Levocetirizine
Dihydrochloride
active
pharmaceutical
ingredient
packaged in
varying grams or
kg in bags or
drums
All lots
Class II
repackaged
and distributed
between
01/05/12 to
02/12/15
Drugs
Levocetirizine HCl
active
pharmaceutical
ingredient
packaged in
varying grams or
kg in bags or
drums
All lots
Class II
repackaged
and distributed
between
01/05/12 to
02/12/15
Copyright© PerformRx, LLC 2015 All Rights Reserved
Reason for Recall
separation which could
introduce the potential
for cross contamination
with penicillin.
Penicillin Cross
Contamination: All lots of
all products repackaged
and distributed between
01/05/12 and 02/12/15
are being recalled
because they were
repackaged in a facility
with penicillin products
without adequate
separation which could
introduce the potential
for cross contamination
with penicillin.
Penicillin Cross
Contamination: All lots of
all products repackaged
and distributed between
01/05/12 and 02/12/15
are being recalled
because they were
repackaged in a facility
with penicillin products
without adequate
separation which could
introduce the potential
for cross contamination
with penicillin.
Penicillin Cross
Contamination: All lots of
all products repackaged
and distributed between
01/05/12 and 02/12/15
are being recalled
because they were
repackaged in a facility
with penicillin products
Recalling firm
Attix
Pharmaceutic
als
Attix
Pharmaceutic
als
Attix
Pharmaceutic
als
109
Product
Type
Product
Description
Code info.
Class
Drugs
Levodopa or LDihydroxyphenyla
lanine active
pharmaceutical
ingredient
packaged in
varying grams or
kg in bags or
drums
All lots
Class II
repackaged
and distributed
between
01/05/12 to
02/12/15
Drugs
Levofloxacin
Hemihydrate
active
pharmaceutical
ingredient
packaged in
varying grams or
kg in bags or
drums
All lots
Class II
repackaged
and distributed
between
01/05/12 to
02/12/15
Drugs
Levomefolate
Calcium or L-5Methyltetrahydro
folate Calcium
active
pharmaceutical
ingredient
packaged in
All lots
Class II
repackaged
and distributed
between
01/05/12 to
02/12/15
Copyright© PerformRx, LLC 2015 All Rights Reserved
Reason for Recall
without adequate
separation which could
introduce the potential
for cross contamination
with penicillin.
Penicillin Cross
Contamination: All lots of
all products repackaged
and distributed between
01/05/12 and 02/12/15
are being recalled
because they were
repackaged in a facility
with penicillin products
without adequate
separation which could
introduce the potential
for cross contamination
with penicillin.
Penicillin Cross
Contamination: All lots of
all products repackaged
and distributed between
01/05/12 and 02/12/15
are being recalled
because they were
repackaged in a facility
with penicillin products
without adequate
separation which could
introduce the potential
for cross contamination
with penicillin.
Penicillin Cross
Contamination: All lots of
all products repackaged
and distributed between
01/05/12 and 02/12/15
are being recalled
because they were
repackaged in a facility
Recalling firm
Attix
Pharmaceutic
als
Attix
Pharmaceutic
als
Attix
Pharmaceutic
als
110
Product
Type
Product
Description
varying grams or
kg in bags or
drums
Code info.
Class
Drugs
Levosulpiride
active
pharmaceutical
ingredient
packaged in
varying grams or
kg in bags or
drums
All lots
Class II
repackaged
and distributed
between
01/05/12 to
02/12/15
Drugs
Levothyroxine
Sodium (T4)
active
pharmaceutical
ingredient
packaged in
varying grams or
kg in bags or
drums
All lots
Class II
repackaged
and distributed
between
01/05/12 to
02/12/15
Drugs
Lidocaine HCl
active
pharmaceutical
ingredient
packaged in
varying grams or
kg in bags or
All lots
Class II
repackaged
and distributed
between
01/05/12 to
02/12/15
Copyright© PerformRx, LLC 2015 All Rights Reserved
Reason for Recall
with penicillin products
without adequate
separation which could
introduce the potential
for cross contamination
with penicillin.
Penicillin Cross
Contamination: All lots of
all products repackaged
and distributed between
01/05/12 and 02/12/15
are being recalled
because they were
repackaged in a facility
with penicillin products
without adequate
separation which could
introduce the potential
for cross contamination
with penicillin.
Penicillin Cross
Contamination: All lots of
all products repackaged
and distributed between
01/05/12 and 02/12/15
are being recalled
because they were
repackaged in a facility
with penicillin products
without adequate
separation which could
introduce the potential
for cross contamination
with penicillin.
Penicillin Cross
Contamination: All lots of
all products repackaged
and distributed between
01/05/12 and 02/12/15
are being recalled
because they were
Recalling firm
Attix
Pharmaceutic
als
Attix
Pharmaceutic
als
Attix
Pharmaceutic
als
111
Product
Type
Product
Description
drums
Code info.
Class
Drugs
Lincomycin HCl
Monohydrate
active
pharmaceutical
ingredient
packaged in
varying grams or
kg in bags or
drums
All lots
Class II
repackaged
and distributed
between
01/05/12 to
02/12/15
Drugs
Linezolid active
pharmaceutical
ingredient
packaged in
varying grams or
kg in bags or
drums
All lots
Class II
repackaged
and distributed
between
01/05/12 to
02/12/15
Drugs
Liothyronine
Sodium (T3)
active
pharmaceutical
ingredient
packaged in
All lots
Class II
repackaged
and distributed
between
01/05/12 to
02/12/15
Copyright© PerformRx, LLC 2015 All Rights Reserved
Reason for Recall
repackaged in a facility
with penicillin products
without adequate
separation which could
introduce the potential
for cross contamination
with penicillin.
Penicillin Cross
Contamination: All lots of
all products repackaged
and distributed between
01/05/12 and 02/12/15
are being recalled
because they were
repackaged in a facility
with penicillin products
without adequate
separation which could
introduce the potential
for cross contamination
with penicillin.
Penicillin Cross
Contamination: All lots of
all products repackaged
and distributed between
01/05/12 and 02/12/15
are being recalled
because they were
repackaged in a facility
with penicillin products
without adequate
separation which could
introduce the potential
for cross contamination
with penicillin.
Penicillin Cross
Contamination: All lots of
all products repackaged
and distributed between
01/05/12 and 02/12/15
are being recalled
Recalling firm
Attix
Pharmaceutic
als
Attix
Pharmaceutic
als
Attix
Pharmaceutic
als
112
Product
Type
Product
Description
varying grams or
kg in bags or
drums
Code info.
Class
Drugs
Lisinopril active
pharmaceutical
ingredient
packaged in
varying grams or
kg in bags or
drums
All lots
Class II
repackaged
and distributed
between
01/05/12 to
02/12/15
Drugs
Lodenafil
Carbonate active
pharmaceutical
ingredient
packaged in
varying grams or
kg in bags or
drums
All lots
Class II
repackaged
and distributed
between
01/05/12 to
02/12/15
Drugs
Lomustine active
pharmaceutical
ingredient
packaged in
varying grams or
All lots
Class II
repackaged
and distributed
between
01/05/12 to
Copyright© PerformRx, LLC 2015 All Rights Reserved
Reason for Recall
because they were
repackaged in a facility
with penicillin products
without adequate
separation which could
introduce the potential
for cross contamination
with penicillin.
Penicillin Cross
Contamination: All lots of
all products repackaged
and distributed between
01/05/12 and 02/12/15
are being recalled
because they were
repackaged in a facility
with penicillin products
without adequate
separation which could
introduce the potential
for cross contamination
with penicillin.
Penicillin Cross
Contamination: All lots of
all products repackaged
and distributed between
01/05/12 and 02/12/15
are being recalled
because they were
repackaged in a facility
with penicillin products
without adequate
separation which could
introduce the potential
for cross contamination
with penicillin.
Penicillin Cross
Contamination: All lots of
all products repackaged
and distributed between
01/05/12 and 02/12/15
Recalling firm
Attix
Pharmaceutic
als
Attix
Pharmaceutic
als
Attix
Pharmaceutic
als
113
Product
Type
Product
Description
kg in bags or
drums
Code info.
Class
Drugs
Loratadine active
pharmaceutical
ingredient
packaged in
varying grams or
kg in bags or
drums
All lots
Class II
repackaged
and distributed
between
01/05/12 to
02/12/15
Drugs
Losartan
Potassium active
pharmaceutical
ingredient
packaged in
varying grams or
kg in bags or
drums
All lots
Class II
repackaged
and distributed
between
01/05/12 to
02/12/15
Drugs
Magnesium
Stearate
pharmaceutical
ingredient
All lots
Class II
repackaged
and distributed
between
02/12/15
Copyright© PerformRx, LLC 2015 All Rights Reserved
Reason for Recall
are being recalled
because they were
repackaged in a facility
with penicillin products
without adequate
separation which could
introduce the potential
for cross contamination
with penicillin.
Penicillin Cross
Contamination: All lots of
all products repackaged
and distributed between
01/05/12 and 02/12/15
are being recalled
because they were
repackaged in a facility
with penicillin products
without adequate
separation which could
introduce the potential
for cross contamination
with penicillin.
Penicillin Cross
Contamination: All lots of
all products repackaged
and distributed between
01/05/12 and 02/12/15
are being recalled
because they were
repackaged in a facility
with penicillin products
without adequate
separation which could
introduce the potential
for cross contamination
with penicillin.
Penicillin Cross
Contamination: All lots of
all products repackaged
and distributed between
Recalling firm
Attix
Pharmaceutic
als
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Pharmaceutic
als
Attix
Pharmaceutic
als
114
Product
Type
Product
Description
packaged in
varying grams or
kg in bags or
drums
Code info.
Class
Drugs
Mebendazole
active
pharmaceutical
ingredient
packaged in
varying grams or
kg in bags or
drums
All lots
Class II
repackaged
and distributed
between
01/05/12 to
02/12/15
Drugs
Mechlorethamine
HCl active
pharmaceutical
ingredient
packaged in
varying grams or
kg in bags or
drums
All lots
Class II
repackaged
and distributed
between
01/05/12 to
02/12/15
Drugs
Meclofenoxate
HCl active
pharmaceutical
All lots
Class II
repackaged
and distributed
01/05/12 to
02/12/15
Copyright© PerformRx, LLC 2015 All Rights Reserved
Reason for Recall
01/05/12 and 02/12/15
are being recalled
because they were
repackaged in a facility
with penicillin products
without adequate
separation which could
introduce the potential
for cross contamination
with penicillin.
Penicillin Cross
Contamination: All lots of
all products repackaged
and distributed between
01/05/12 and 02/12/15
are being recalled
because they were
repackaged in a facility
with penicillin products
without adequate
separation which could
introduce the potential
for cross contamination
with penicillin.
Penicillin Cross
Contamination: All lots of
all products repackaged
and distributed between
01/05/12 and 02/12/15
are being recalled
because they were
repackaged in a facility
with penicillin products
without adequate
separation which could
introduce the potential
for cross contamination
with penicillin.
Penicillin Cross
Contamination: All lots of
all products repackaged
Recalling firm
Attix
Pharmaceutic
als
Attix
Pharmaceutic
als
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Pharmaceutic
als
115
Product
Type
Product
Description
ingredient
packaged in
varying grams or
kg in bags or
drums
Code info.
Class
Drugs
Mefloquine HCl
active
pharmaceutical
ingredient
packaged in
varying grams or
kg in bags or
drums
All lots
Class II
repackaged
and distributed
between
01/05/12 to
02/12/15
Drugs
Meloxicam active
pharmaceutical
ingredient
packaged in
varying grams or
kg in bags or
drums
All lots
Class II
repackaged
and distributed
between
01/05/12 to
02/12/15
Drugs
Melphalan active
pharmaceutical
All lots
repackaged
between
01/05/12 to
02/12/15
Class II
Copyright© PerformRx, LLC 2015 All Rights Reserved
Reason for Recall
and distributed between
01/05/12 and 02/12/15
are being recalled
because they were
repackaged in a facility
with penicillin products
without adequate
separation which could
introduce the potential
for cross contamination
with penicillin.
Penicillin Cross
Contamination: All lots of
all products repackaged
and distributed between
01/05/12 and 02/12/15
are being recalled
because they were
repackaged in a facility
with penicillin products
without adequate
separation which could
introduce the potential
for cross contamination
with penicillin.
Penicillin Cross
Contamination: All lots of
all products repackaged
and distributed between
01/05/12 and 02/12/15
are being recalled
because they were
repackaged in a facility
with penicillin products
without adequate
separation which could
introduce the potential
for cross contamination
with penicillin.
Penicillin Cross
Contamination: All lots of
Recalling firm
Attix
Pharmaceutic
als
Attix
Pharmaceutic
als
Attix
Pharmaceutic
116
Product
Type
Product
Description
ingredient
packaged in
varying grams or
kg in bags or
drums
Code info.
Class
Drugs
Memantine HCl
active
pharmaceutical
ingredient
packaged in
varying grams or
kg in bags or
drums
All lots
Class II
repackaged
and distributed
between
01/05/12 to
02/12/15
Drugs
Mepivacaine HCl
active
pharmaceutical
ingredient
packaged in
varying grams or
kg in bags or
drums
All lots
Class II
repackaged
and distributed
between
01/05/12 to
02/12/15
Drugs
Metaxalone
All lots
and distributed
between
01/05/12 to
02/12/15
Class II
Copyright© PerformRx, LLC 2015 All Rights Reserved
Reason for Recall
Recalling firm
all products repackaged
and distributed between
01/05/12 and 02/12/15
are being recalled
because they were
repackaged in a facility
with penicillin products
without adequate
separation which could
introduce the potential
for cross contamination
with penicillin.
Penicillin Cross
Contamination: All lots of
all products repackaged
and distributed between
01/05/12 and 02/12/15
are being recalled
because they were
repackaged in a facility
with penicillin products
without adequate
separation which could
introduce the potential
for cross contamination
with penicillin.
Penicillin Cross
Contamination: All lots of
all products repackaged
and distributed between
01/05/12 and 02/12/15
are being recalled
because they were
repackaged in a facility
with penicillin products
without adequate
separation which could
introduce the potential
for cross contamination
with penicillin.
Penicillin Cross
als
Attix
Pharmaceutic
als
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Pharmaceutic
als
Attix
117
Product
Type
Product
Description
active
pharmaceutical
ingredient
packaged in
varying grams or
kg in bags or
drums
Code info.
Class
Drugs
Metformin HCl
active
pharmaceutical
ingredient
packaged in
varying grams or
kg in bags or
drums
All lots
Class II
repackaged
and distributed
between
01/05/12 to
02/12/15
Drugs
Methimazole
active
pharmaceutical
ingredient
packaged in
varying grams or
kg in bags or
drums
All lots
Class II
repackaged
and distributed
between
01/05/12 to
02/12/15
repackaged
and distributed
between
01/05/12 to
02/12/15
Copyright© PerformRx, LLC 2015 All Rights Reserved
Reason for Recall
Recalling firm
Contamination: All lots of
all products repackaged
and distributed between
01/05/12 and 02/12/15
are being recalled
because they were
repackaged in a facility
with penicillin products
without adequate
separation which could
introduce the potential
for cross contamination
with penicillin.
Penicillin Cross
Contamination: All lots of
all products repackaged
and distributed between
01/05/12 and 02/12/15
are being recalled
because they were
repackaged in a facility
with penicillin products
without adequate
separation which could
introduce the potential
for cross contamination
with penicillin.
Penicillin Cross
Contamination: All lots of
all products repackaged
and distributed between
01/05/12 and 02/12/15
are being recalled
because they were
repackaged in a facility
with penicillin products
without adequate
separation which could
introduce the potential
for cross contamination
with penicillin.
Pharmaceutic
als
Attix
Pharmaceutic
als
Attix
Pharmaceutic
als
118
Product
Type
Drugs
Product
Description
Methazolamide
active
pharmaceutical
ingredient
packaged in
varying grams or
kg in bags or
drums
Code info.
Class
Drugs
Methocarbamol
active
pharmaceutical
ingredient
packaged in
varying grams or
kg in bags or
drums
All lots
Class II
repackaged
and distributed
between
01/05/12 to
02/12/15
Drugs
Methotrexate
Sodium active
pharmaceutical
ingredient
packaged in
varying grams or
kg in bags or
drums
All lots
Class II
repackaged
and distributed
between
01/05/12 to
02/12/15
All lots
Class II
repackaged
and distributed
between
01/05/12 to
02/12/15
Copyright© PerformRx, LLC 2015 All Rights Reserved
Reason for Recall
Recalling firm
Penicillin Cross
Contamination: All lots of
all products repackaged
and distributed between
01/05/12 and 02/12/15
are being recalled
because they were
repackaged in a facility
with penicillin products
without adequate
separation which could
introduce the potential
for cross contamination
with penicillin.
Penicillin Cross
Contamination: All lots of
all products repackaged
and distributed between
01/05/12 and 02/12/15
are being recalled
because they were
repackaged in a facility
with penicillin products
without adequate
separation which could
introduce the potential
for cross contamination
with penicillin.
Penicillin Cross
Contamination: All lots of
all products repackaged
and distributed between
01/05/12 and 02/12/15
are being recalled
because they were
repackaged in a facility
with penicillin products
without adequate
separation which could
introduce the potential
for cross contamination
Attix
Pharmaceutic
als
Attix
Pharmaceutic
als
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Pharmaceutic
als
119
Product
Type
Product
Description
Code info.
Class
Drugs
Methotrexate
USP active
pharmaceutical
ingredient
packaged in
varying grams or
kg in bags or
drums
All lots
Class II
repackaged
and distributed
between
01/05/12 to
02/12/15
Drugs
Methscopolamin
e Bromide active
pharmaceutical
ingredient
packaged in
varying grams or
kg in bags or
drums
All lots
Class II
repackaged
and distributed
between
01/05/12 to
02/12/15
Drugs
Methscopolamin
e Bromide Combo
active
pharmaceutical
ingredient
packaged in
varying grams or
kg in bags or
drums
All lots
Class II
repackaged
and distributed
between
01/05/12 to
02/12/15
Copyright© PerformRx, LLC 2015 All Rights Reserved
Reason for Recall
with penicillin.
Penicillin Cross
Contamination: All lots of
all products repackaged
and distributed between
01/05/12 and 02/12/15
are being recalled
because they were
repackaged in a facility
with penicillin products
without adequate
separation which could
introduce the potential
for cross contamination
with penicillin.
Penicillin Cross
Contamination: All lots of
all products repackaged
and distributed between
01/05/12 and 02/12/15
are being recalled
because they were
repackaged in a facility
with penicillin products
without adequate
separation which could
introduce the potential
for cross contamination
with penicillin.
Penicillin Cross
Contamination: All lots of
all products repackaged
and distributed between
01/05/12 and 02/12/15
are being recalled
because they were
repackaged in a facility
with penicillin products
without adequate
separation which could
introduce the potential
Recalling firm
Attix
Pharmaceutic
als
Attix
Pharmaceutic
als
Attix
Pharmaceutic
als
120
Product
Type
Product
Description
Code info.
Class
Drugs
Methyl 5Aminolevulinate
Hydrochloride
active
pharmaceutical
ingredient
packaged in
varying grams or
kg in bags or
drums
All lots
Class II
repackaged
and distributed
between
01/05/12 to
02/12/15
Drugs
Methyl Folate
Calcium active
pharmaceutical
ingredient
packaged in
varying grams or
kg in bags or
drums
All lots
Class II
repackaged
and distributed
between
01/05/12 to
02/12/15
Drugs
Methylprednisolo
ne Acetate active
pharmaceutical
ingredient
packaged in
varying grams or
kg in bags or
drums
All lots
Class II
repackaged
and distributed
between
01/05/12 to
02/12/15
Copyright© PerformRx, LLC 2015 All Rights Reserved
Reason for Recall
for cross contamination
with penicillin.
Penicillin Cross
Contamination: All lots of
all products repackaged
and distributed between
01/05/12 and 02/12/15
are being recalled
because they were
repackaged in a facility
with penicillin products
without adequate
separation which could
introduce the potential
for cross contamination
with penicillin.
Penicillin Cross
Contamination: All lots of
all products repackaged
and distributed between
01/05/12 and 02/12/15
are being recalled
because they were
repackaged in a facility
with penicillin products
without adequate
separation which could
introduce the potential
for cross contamination
with penicillin.
Penicillin Cross
Contamination: All lots of
all products repackaged
and distributed between
01/05/12 and 02/12/15
are being recalled
because they were
repackaged in a facility
with penicillin products
without adequate
separation which could
Recalling firm
Attix
Pharmaceutic
als
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Pharmaceutic
als
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Pharmaceutic
als
121
Product
Type
Product
Description
Code info.
Class
Drugs
Methylprednisolo
ne Base active
pharmaceutical
ingredient
packaged in
varying grams or
kg in bags or
drums
All lots
Class II
repackaged
and distributed
between
01/05/12 to
02/12/15
Drugs
Metronidazole
Base active
pharmaceutical
ingredient
packaged in
varying grams or
kg in bags or
drums
All lots
Class II
repackaged
and distributed
between
01/05/12 to
02/12/15
Drugs
Metronidazole
Benzoate active
pharmaceutical
ingredient
packaged in
varying grams or
kg in bags or
drums
All lots
Class II
repackaged
and distributed
between
01/05/12 to
02/12/15
Copyright© PerformRx, LLC 2015 All Rights Reserved
Reason for Recall
introduce the potential
for cross contamination
with penicillin.
Penicillin Cross
Contamination: All lots of
all products repackaged
and distributed between
01/05/12 and 02/12/15
are being recalled
because they were
repackaged in a facility
with penicillin products
without adequate
separation which could
introduce the potential
for cross contamination
with penicillin.
Penicillin Cross
Contamination: All lots of
all products repackaged
and distributed between
01/05/12 and 02/12/15
are being recalled
because they were
repackaged in a facility
with penicillin products
without adequate
separation which could
introduce the potential
for cross contamination
with penicillin.
Penicillin Cross
Contamination: All lots of
all products repackaged
and distributed between
01/05/12 and 02/12/15
are being recalled
because they were
repackaged in a facility
with penicillin products
without adequate
Recalling firm
Attix
Pharmaceutic
als
Attix
Pharmaceutic
als
Attix
Pharmaceutic
als
122
Product
Type
Product
Description
Code info.
Class
Drugs
Mevastatin active
pharmaceutical
ingredient
packaged in
varying grams or
kg in bags or
drums
All lots
Class II
repackaged
and distributed
between
01/05/12 to
02/12/15
Drugs
Mexiletine HCl
active
pharmaceutical
ingredient
packaged in
varying grams or
kg in bags or
drums
All lots
Class II
repackaged
and distributed
between
01/05/12 to
02/12/15
Drugs
Miconazole
Nitrate active
pharmaceutical
ingredient
packaged in
varying grams or
kg in bags or
drums
All lots
Class II
repackaged
and distributed
between
01/05/12 to
02/12/15
Copyright© PerformRx, LLC 2015 All Rights Reserved
Reason for Recall
separation which could
introduce the potential
for cross contamination
with penicillin.
Penicillin Cross
Contamination: All lots of
all products repackaged
and distributed between
01/05/12 and 02/12/15
are being recalled
because they were
repackaged in a facility
with penicillin products
without adequate
separation which could
introduce the potential
for cross contamination
with penicillin.
Penicillin Cross
Contamination: All lots of
all products repackaged
and distributed between
01/05/12 and 02/12/15
are being recalled
because they were
repackaged in a facility
with penicillin products
without adequate
separation which could
introduce the potential
for cross contamination
with penicillin.
Penicillin Cross
Contamination: All lots of
all products repackaged
and distributed between
01/05/12 and 02/12/15
are being recalled
because they were
repackaged in a facility
with penicillin products
Recalling firm
Attix
Pharmaceutic
als
Attix
Pharmaceutic
als
Attix
Pharmaceutic
als
123
Product
Type
Product
Description
Code info.
Class
Drugs
Miltefosine active
pharmaceutical
ingredient
packaged in
varying grams or
kg in bags or
drums
All lots
Class II
repackaged
and distributed
between
01/05/12 to
02/12/15
Drugs
Minocycline HCl
active
pharmaceutical
ingredient
packaged in
varying grams or
kg in bags or
drums
All lots
Class II
repackaged
and distributed
between
01/05/12 to
02/12/15
Drugs
Minoxidil active
pharmaceutical
ingredient
packaged in
varying grams or
kg in bags or
drums
All lots
Class II
repackaged
and distributed
between
01/05/12 to
02/12/15
Copyright© PerformRx, LLC 2015 All Rights Reserved
Reason for Recall
without adequate
separation which could
introduce the potential
for cross contamination
with penicillin.
Penicillin Cross
Contamination: All lots of
all products repackaged
and distributed between
01/05/12 and 02/12/15
are being recalled
because they were
repackaged in a facility
with penicillin products
without adequate
separation which could
introduce the potential
for cross contamination
with penicillin.
Penicillin Cross
Contamination: All lots of
all products repackaged
and distributed between
01/05/12 and 02/12/15
are being recalled
because they were
repackaged in a facility
with penicillin products
without adequate
separation which could
introduce the potential
for cross contamination
with penicillin.
Penicillin Cross
Contamination: All lots of
all products repackaged
and distributed between
01/05/12 and 02/12/15
are being recalled
because they were
repackaged in a facility
Recalling firm
Attix
Pharmaceutic
als
Attix
Pharmaceutic
als
Attix
Pharmaceutic
als
124
Product
Type
Product
Description
Code info.
Class
Drugs
Mirtazapine
active
pharmaceutical
ingredient
packaged in
varying grams or
kg in bags or
drums
All lots
Class II
repackaged
and distributed
between
01/05/12 to
02/12/15
Drugs
Misoprostol 1%
active
pharmaceutical
ingredient
packaged in
varying grams or
kg in bags or
drums
All lots
Class II
repackaged
and distributed
between
01/05/12 to
02/12/15
Drugs
Mitomycin C
active
pharmaceutical
ingredient
packaged in
varying grams or
kg in bags or
All lots
Class II
repackaged
and distributed
between
01/05/12 to
02/12/15
Copyright© PerformRx, LLC 2015 All Rights Reserved
Reason for Recall
with penicillin products
without adequate
separation which could
introduce the potential
for cross contamination
with penicillin.
Penicillin Cross
Contamination: All lots of
all products repackaged
and distributed between
01/05/12 and 02/12/15
are being recalled
because they were
repackaged in a facility
with penicillin products
without adequate
separation which could
introduce the potential
for cross contamination
with penicillin.
Penicillin Cross
Contamination: All lots of
all products repackaged
and distributed between
01/05/12 and 02/12/15
are being recalled
because they were
repackaged in a facility
with penicillin products
without adequate
separation which could
introduce the potential
for cross contamination
with penicillin.
Penicillin Cross
Contamination: All lots of
all products repackaged
and distributed between
01/05/12 and 02/12/15
are being recalled
because they were
Recalling firm
Attix
Pharmaceutic
als
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Pharmaceutic
als
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Pharmaceutic
als
125
Product
Type
Product
Description
drums
Code info.
Class
Drugs
Mitotane active
pharmaceutical
ingredient
packaged in
varying grams or
kg in bags or
drums
All lots
Class II
repackaged
and distributed
between
01/05/12 to
02/12/15
Drugs
Mometasone
Furoate active
pharmaceutical
ingredient
packaged in
varying grams or
kg in bags or
drums
All lots
Class II
repackaged
and distributed
between
01/05/12 to
02/12/15
Drugs
Monobenzone
active
pharmaceutical
ingredient
packaged in
varying grams or
All lots
Class II
repackaged
and distributed
between
01/05/12 to
02/12/15
Copyright© PerformRx, LLC 2015 All Rights Reserved
Reason for Recall
repackaged in a facility
with penicillin products
without adequate
separation which could
introduce the potential
for cross contamination
with penicillin.
Penicillin Cross
Contamination: All lots of
all products repackaged
and distributed between
01/05/12 and 02/12/15
are being recalled
because they were
repackaged in a facility
with penicillin products
without adequate
separation which could
introduce the potential
for cross contamination
with penicillin.
Penicillin Cross
Contamination: All lots of
all products repackaged
and distributed between
01/05/12 and 02/12/15
are being recalled
because they were
repackaged in a facility
with penicillin products
without adequate
separation which could
introduce the potential
for cross contamination
with penicillin.
Penicillin Cross
Contamination: All lots of
all products repackaged
and distributed between
01/05/12 and 02/12/15
are being recalled
Recalling firm
Attix
Pharmaceutic
als
Attix
Pharmaceutic
als
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als
126
Product
Type
Product
Description
kg in bags or
drums
Code info.
Class
Drugs
Montelukast
Sodium active
pharmaceutical
ingredient
packaged in
varying grams or
kg in bags or
drums
All lots
Class II
repackaged
and distributed
between
01/05/12 to
02/12/15
Drugs
Moxifloxacin HCl
active
pharmaceutical
ingredient
packaged in
varying grams or
kg in bags or
drums
All lots
Class II
repackaged
and distributed
between
01/05/12 to
02/12/15
Drugs
Mupirocin active
pharmaceutical
ingredient
packaged in
varying grams or
All lots
Class II
repackaged
and distributed
between
01/05/12 to
Copyright© PerformRx, LLC 2015 All Rights Reserved
Reason for Recall
because they were
repackaged in a facility
with penicillin products
without adequate
separation which could
introduce the potential
for cross contamination
with penicillin.
Penicillin Cross
Contamination: All lots of
all products repackaged
and distributed between
01/05/12 and 02/12/15
are being recalled
because they were
repackaged in a facility
with penicillin products
without adequate
separation which could
introduce the potential
for cross contamination
with penicillin.
Penicillin Cross
Contamination: All lots of
all products repackaged
and distributed between
01/05/12 and 02/12/15
are being recalled
because they were
repackaged in a facility
with penicillin products
without adequate
separation which could
introduce the potential
for cross contamination
with penicillin.
Penicillin Cross
Contamination: All lots of
all products repackaged
and distributed between
01/05/12 and 02/12/15
Recalling firm
Attix
Pharmaceutic
als
Attix
Pharmaceutic
als
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als
127
Product
Type
Product
Description
kg in bags or
drums
Code info.
Class
Drugs
Mycophenolate
Mofetil active
pharmaceutical
ingredient
packaged in
varying grams or
kg in bags or
drums
All lots
Class II
repackaged
and distributed
between
01/05/12 to
02/12/15
Drugs
Naftifine HCl
active
pharmaceutical
ingredient
packaged in
varying grams or
kg in bags or
drums
All lots
Class II
repackaged
and distributed
between
01/05/12 to
02/12/15
Drugs
Naproxen Base
active
pharmaceutical
ingredient
All lots
Class II
repackaged
and distributed
between
02/12/15
Copyright© PerformRx, LLC 2015 All Rights Reserved
Reason for Recall
are being recalled
because they were
repackaged in a facility
with penicillin products
without adequate
separation which could
introduce the potential
for cross contamination
with penicillin.
Penicillin Cross
Contamination: All lots of
all products repackaged
and distributed between
01/05/12 and 02/12/15
are being recalled
because they were
repackaged in a facility
with penicillin products
without adequate
separation which could
introduce the potential
for cross contamination
with penicillin.
Penicillin Cross
Contamination: All lots of
all products repackaged
and distributed between
01/05/12 and 02/12/15
are being recalled
because they were
repackaged in a facility
with penicillin products
without adequate
separation which could
introduce the potential
for cross contamination
with penicillin.
Penicillin Cross
Contamination: All lots of
all products repackaged
and distributed between
Recalling firm
Attix
Pharmaceutic
als
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als
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als
128
Product
Type
Product
Description
packaged in
varying grams or
kg in bags or
drums
Code info.
Class
Drugs
Naproxen Sodium
active
pharmaceutical
ingredient
packaged in
varying grams or
kg in bags or
drums
All lots
Class II
repackaged
and distributed
between
01/05/12 to
02/12/15
Drugs
Natamycin active
pharmaceutical
ingredient
packaged in
varying grams or
kg in bags or
drums
All lots
Class II
repackaged
and distributed
between
01/05/12 to
02/12/15
Drugs
Neostigmine
Methylsulfate
active
All lots
Class II
repackaged
and distributed
01/05/12 to
02/12/15
Copyright© PerformRx, LLC 2015 All Rights Reserved
Reason for Recall
01/05/12 and 02/12/15
are being recalled
because they were
repackaged in a facility
with penicillin products
without adequate
separation which could
introduce the potential
for cross contamination
with penicillin.
Penicillin Cross
Contamination: All lots of
all products repackaged
and distributed between
01/05/12 and 02/12/15
are being recalled
because they were
repackaged in a facility
with penicillin products
without adequate
separation which could
introduce the potential
for cross contamination
with penicillin.
Penicillin Cross
Contamination: All lots of
all products repackaged
and distributed between
01/05/12 and 02/12/15
are being recalled
because they were
repackaged in a facility
with penicillin products
without adequate
separation which could
introduce the potential
for cross contamination
with penicillin.
Penicillin Cross
Contamination: All lots of
all products repackaged
Recalling firm
Attix
Pharmaceutic
als
Attix
Pharmaceutic
als
Attix
Pharmaceutic
als
129
Product
Type
Product
Description
pharmaceutical
ingredient
packaged in
varying grams or
kg in bags or
drums
Code info.
Class
Drugs
Nevirapine active
pharmaceutical
ingredient
packaged in
varying grams or
kg in bags or
drums
All lots
Class II
repackaged
and distributed
between
01/05/12 to
02/12/15
Drugs
Nilotinib active
pharmaceutical
ingredient
packaged in
varying grams or
kg in bags or
drums
All lots
Class II
repackaged
and distributed
between
01/05/12 to
02/12/15
Drugs
Nitazoxanide
active
All lots
repackaged
between
01/05/12 to
02/12/15
Class II
Copyright© PerformRx, LLC 2015 All Rights Reserved
Reason for Recall
and distributed between
01/05/12 and 02/12/15
are being recalled
because they were
repackaged in a facility
with penicillin products
without adequate
separation which could
introduce the potential
for cross contamination
with penicillin.
Penicillin Cross
Contamination: All lots of
all products repackaged
and distributed between
01/05/12 and 02/12/15
are being recalled
because they were
repackaged in a facility
with penicillin products
without adequate
separation which could
introduce the potential
for cross contamination
with penicillin.
Penicillin Cross
Contamination: All lots of
all products repackaged
and distributed between
01/05/12 and 02/12/15
are being recalled
because they were
repackaged in a facility
with penicillin products
without adequate
separation which could
introduce the potential
for cross contamination
with penicillin.
Penicillin Cross
Contamination: All lots of
Recalling firm
Attix
Pharmaceutic
als
Attix
Pharmaceutic
als
Attix
Pharmaceutic
130
Product
Type
Product
Description
pharmaceutical
ingredient
packaged in
varying grams or
kg in bags or
drums
Code info.
Class
Drugs
Nitrofurantoin
active
pharmaceutical
ingredient
packaged in
varying grams or
kg in bags or
drums
All lots
Class II
repackaged
and distributed
between
01/05/12 to
02/12/15
Drugs
Norethindrone
Acetate active
pharmaceutical
ingredient
packaged in
varying grams or
kg in bags or
drums
All lots
Class II
repackaged
and distributed
between
01/05/12 to
02/12/15
Drugs
Ofloxacin active
All lots
and distributed
between
01/05/12 to
02/12/15
Class II
Copyright© PerformRx, LLC 2015 All Rights Reserved
Reason for Recall
Recalling firm
all products repackaged
and distributed between
01/05/12 and 02/12/15
are being recalled
because they were
repackaged in a facility
with penicillin products
without adequate
separation which could
introduce the potential
for cross contamination
with penicillin.
Penicillin Cross
Contamination: All lots of
all products repackaged
and distributed between
01/05/12 and 02/12/15
are being recalled
because they were
repackaged in a facility
with penicillin products
without adequate
separation which could
introduce the potential
for cross contamination
with penicillin.
Penicillin Cross
Contamination: All lots of
all products repackaged
and distributed between
01/05/12 and 02/12/15
are being recalled
because they were
repackaged in a facility
with penicillin products
without adequate
separation which could
introduce the potential
for cross contamination
with penicillin.
Penicillin Cross
als
Attix
Pharmaceutic
als
Attix
Pharmaceutic
als
Attix
131
Product
Type
Product
Description
pharmaceutical
ingredient
packaged in
varying grams or
kg in bags or
drums
Code info.
Class
Drugs
Olsalazine
Sodium active
pharmaceutical
ingredient
packaged in
varying grams or
kg in bags or
drums
All lots
Class II
repackaged
and distributed
between
01/05/12 to
02/12/15
Drugs
Omeprazole
active
pharmaceutical
ingredient
packaged in
varying grams or
kg in bags or
drums
All lots
Class II
repackaged
and distributed
between
01/05/12 to
02/12/15
repackaged
and distributed
between
01/05/12 to
02/12/15
Copyright© PerformRx, LLC 2015 All Rights Reserved
Reason for Recall
Recalling firm
Contamination: All lots of
all products repackaged
and distributed between
01/05/12 and 02/12/15
are being recalled
because they were
repackaged in a facility
with penicillin products
without adequate
separation which could
introduce the potential
for cross contamination
with penicillin.
Penicillin Cross
Contamination: All lots of
all products repackaged
and distributed between
01/05/12 and 02/12/15
are being recalled
because they were
repackaged in a facility
with penicillin products
without adequate
separation which could
introduce the potential
for cross contamination
with penicillin.
Penicillin Cross
Contamination: All lots of
all products repackaged
and distributed between
01/05/12 and 02/12/15
are being recalled
because they were
repackaged in a facility
with penicillin products
without adequate
separation which could
introduce the potential
for cross contamination
with penicillin.
Pharmaceutic
als
Attix
Pharmaceutic
als
Attix
Pharmaceutic
als
132
Product
Type
Drugs
Product
Description
Omeprazole
Sodium active
pharmaceutical
ingredient
packaged in
varying grams or
kg in bags or
drums
Code info.
Class
Drugs
Ondansetron HCl
Dihydrate active
pharmaceutical
ingredient
packaged in
varying grams or
kg in bags or
drums
All lots
Class II
repackaged
and distributed
between
01/05/12 to
02/12/15
Drugs
Orphenadrine
Citrate active
pharmaceutical
ingredient
packaged in
varying grams or
kg in bags or
drums
All lots
Class II
repackaged
and distributed
between
01/05/12 to
02/12/15
All lots
Class II
repackaged
and distributed
between
01/05/12 to
02/12/15
Copyright© PerformRx, LLC 2015 All Rights Reserved
Reason for Recall
Recalling firm
Penicillin Cross
Contamination: All lots of
all products repackaged
and distributed between
01/05/12 and 02/12/15
are being recalled
because they were
repackaged in a facility
with penicillin products
without adequate
separation which could
introduce the potential
for cross contamination
with penicillin.
Penicillin Cross
Contamination: All lots of
all products repackaged
and distributed between
01/05/12 and 02/12/15
are being recalled
because they were
repackaged in a facility
with penicillin products
without adequate
separation which could
introduce the potential
for cross contamination
with penicillin.
Penicillin Cross
Contamination: All lots of
all products repackaged
and distributed between
01/05/12 and 02/12/15
are being recalled
because they were
repackaged in a facility
with penicillin products
without adequate
separation which could
introduce the potential
for cross contamination
Attix
Pharmaceutic
als
Attix
Pharmaceutic
als
Attix
Pharmaceutic
als
133
Product
Type
Product
Description
Code info.
Class
Drugs
Oseltamivir
Phosphate active
pharmaceutical
ingredient
packaged in
varying grams or
kg in bags or
drums
All lots
Class II
repackaged
and distributed
between
01/05/12 to
02/12/15
Drugs
Oxcarbazepine
active
pharmaceutical
ingredient
packaged in
varying grams or
kg in bags or
drums
All lots
Class II
repackaged
and distributed
between
01/05/12 to
02/12/15
Drugs
Paclitaxel SemiSynthetic active
pharmaceutical
ingredient
packaged in
varying grams or
kg in bags or
drums
All lots
Class II
repackaged
and distributed
between
01/05/12 to
02/12/15
Copyright© PerformRx, LLC 2015 All Rights Reserved
Reason for Recall
with penicillin.
Penicillin Cross
Contamination: All lots of
all products repackaged
and distributed between
01/05/12 and 02/12/15
are being recalled
because they were
repackaged in a facility
with penicillin products
without adequate
separation which could
introduce the potential
for cross contamination
with penicillin.
Penicillin Cross
Contamination: All lots of
all products repackaged
and distributed between
01/05/12 and 02/12/15
are being recalled
because they were
repackaged in a facility
with penicillin products
without adequate
separation which could
introduce the potential
for cross contamination
with penicillin.
Penicillin Cross
Contamination: All lots of
all products repackaged
and distributed between
01/05/12 and 02/12/15
are being recalled
because they were
repackaged in a facility
with penicillin products
without adequate
separation which could
introduce the potential
Recalling firm
Attix
Pharmaceutic
als
Attix
Pharmaceutic
als
Attix
Pharmaceutic
als
134
Product
Type
Product
Description
Code info.
Class
Drugs
Pancuronium
Bromide active
pharmaceutical
ingredient
packaged in
varying grams or
kg in bags or
drums
All lots
Class II
repackaged
and distributed
between
01/05/12 to
02/12/15
Drugs
Pantoprazole
Sodium
Monohydrate
active
pharmaceutical
ingredient
packaged in
varying grams or
kg in bags or
drums
All lots
Class II
repackaged
and distributed
between
01/05/12 to
02/12/15
Drugs
Paromomycin
Sulphate active
pharmaceutical
ingredient
packaged in
varying grams or
kg in bags or
drums
All lots
Class II
repackaged
and distributed
between
01/05/12 to
02/12/15
Copyright© PerformRx, LLC 2015 All Rights Reserved
Reason for Recall
for cross contamination
with penicillin.
Penicillin Cross
Contamination: All lots of
all products repackaged
and distributed between
01/05/12 and 02/12/15
are being recalled
because they were
repackaged in a facility
with penicillin products
without adequate
separation which could
introduce the potential
for cross contamination
with penicillin.
Penicillin Cross
Contamination: All lots of
all products repackaged
and distributed between
01/05/12 and 02/12/15
are being recalled
because they were
repackaged in a facility
with penicillin products
without adequate
separation which could
introduce the potential
for cross contamination
with penicillin.
Penicillin Cross
Contamination: All lots of
all products repackaged
and distributed between
01/05/12 and 02/12/15
are being recalled
because they were
repackaged in a facility
with penicillin products
without adequate
separation which could
Recalling firm
Attix
Pharmaceutic
als
Attix
Pharmaceutic
als
Attix
Pharmaceutic
als
135
Product
Type
Product
Description
Code info.
Class
Drugs
Paroxetine active
pharmaceutical
ingredient
packaged in
varying grams or
kg in bags or
drums
All lots
Class II
repackaged
and distributed
between
01/05/12 to
02/12/15
Drugs
Paroxetine HCl
active
pharmaceutical
ingredient
packaged in
varying grams or
kg in bags or
drums
All lots
Class II
repackaged
and distributed
between
01/05/12 to
02/12/15
Drugs
Penciclovir active
pharmaceutical
ingredient
packaged in
varying grams or
kg in bags or
drums
All lots
Class II
repackaged
and distributed
between
01/05/12 to
02/12/15
Copyright© PerformRx, LLC 2015 All Rights Reserved
Reason for Recall
introduce the potential
for cross contamination
with penicillin.
Penicillin Cross
Contamination: All lots of
all products repackaged
and distributed between
01/05/12 and 02/12/15
are being recalled
because they were
repackaged in a facility
with penicillin products
without adequate
separation which could
introduce the potential
for cross contamination
with penicillin.
Penicillin Cross
Contamination: All lots of
all products repackaged
and distributed between
01/05/12 and 02/12/15
are being recalled
because they were
repackaged in a facility
with penicillin products
without adequate
separation which could
introduce the potential
for cross contamination
with penicillin.
Penicillin Cross
Contamination: All lots of
all products repackaged
and distributed between
01/05/12 and 02/12/15
are being recalled
because they were
repackaged in a facility
with penicillin products
without adequate
Recalling firm
Attix
Pharmaceutic
als
Attix
Pharmaceutic
als
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Pharmaceutic
als
136
Product
Type
Product
Description
Code info.
Class
Drugs
Pentosan
Polysulfate
Sodium active
pharmaceutical
ingredient
packaged in
varying grams or
kg in bags or
drums
All lots
Class II
repackaged
and distributed
between
01/05/12 to
02/12/15
Drugs
Pergolide
Mesylate active
pharmaceutical
ingredient
packaged in
varying grams or
kg in bags or
drums
All lots
Class II
repackaged
and distributed
between
01/05/12 to
02/12/15
Drugs
Pheniramine
Maleate active
pharmaceutical
ingredient
packaged in
varying grams or
kg in bags or
drums
All lots
Class II
repackaged
and distributed
between
01/05/12 to
02/12/15
Copyright© PerformRx, LLC 2015 All Rights Reserved
Reason for Recall
separation which could
introduce the potential
for cross contamination
with penicillin.
Penicillin Cross
Contamination: All lots of
all products repackaged
and distributed between
01/05/12 and 02/12/15
are being recalled
because they were
repackaged in a facility
with penicillin products
without adequate
separation which could
introduce the potential
for cross contamination
with penicillin.
Penicillin Cross
Contamination: All lots of
all products repackaged
and distributed between
01/05/12 and 02/12/15
are being recalled
because they were
repackaged in a facility
with penicillin products
without adequate
separation which could
introduce the potential
for cross contamination
with penicillin.
Penicillin Cross
Contamination: All lots of
all products repackaged
and distributed between
01/05/12 and 02/12/15
are being recalled
because they were
repackaged in a facility
with penicillin products
Recalling firm
Attix
Pharmaceutic
als
Attix
Pharmaceutic
als
Attix
Pharmaceutic
als
137
Product
Type
Product
Description
Code info.
Class
Drugs
Phenolphthalein
active
pharmaceutical
ingredient
packaged in
varying grams or
kg in bags or
drums
All lots
Class II
repackaged
and distributed
between
01/05/12 to
02/12/15
Drugs
Phenoxybenzami
ne HCl active
pharmaceutical
ingredient
packaged in
varying grams or
kg in bags or
drums
All lots
Class II
repackaged
and distributed
between
01/05/12 to
02/12/15
Drugs
Phentolamine
Mesylate active
pharmaceutical
ingredient
packaged in
varying grams or
kg in bags or
drums
All lots
Class II
repackaged
and distributed
between
01/05/12 to
02/12/15
Copyright© PerformRx, LLC 2015 All Rights Reserved
Reason for Recall
without adequate
separation which could
introduce the potential
for cross contamination
with penicillin.
Penicillin Cross
Contamination: All lots of
all products repackaged
and distributed between
01/05/12 and 02/12/15
are being recalled
because they were
repackaged in a facility
with penicillin products
without adequate
separation which could
introduce the potential
for cross contamination
with penicillin.
Penicillin Cross
Contamination: All lots of
all products repackaged
and distributed between
01/05/12 and 02/12/15
are being recalled
because they were
repackaged in a facility
with penicillin products
without adequate
separation which could
introduce the potential
for cross contamination
with penicillin.
Penicillin Cross
Contamination: All lots of
all products repackaged
and distributed between
01/05/12 and 02/12/15
are being recalled
because they were
repackaged in a facility
Recalling firm
Attix
Pharmaceutic
als
Attix
Pharmaceutic
als
Attix
Pharmaceutic
als
138
Product
Type
Product
Description
Code info.
Class
Drugs
Pimecrolimus
active
pharmaceutical
ingredient
packaged in
varying grams or
kg in bags or
drums
All lots
Class II
repackaged
and distributed
between
01/05/12 to
02/12/15
Drugs
Pioglitazone HCl
active
pharmaceutical
ingredient
packaged in
varying grams or
kg in bags or
drums
All lots
Class II
repackaged
and distributed
between
01/05/12 to
02/12/15
Drugs
Piperacillin
Sodium active
pharmaceutical
ingredient
packaged in
varying grams or
kg in bags or
All lots
Class II
repackaged
and distributed
between
01/05/12 to
02/12/15
Copyright© PerformRx, LLC 2015 All Rights Reserved
Reason for Recall
with penicillin products
without adequate
separation which could
introduce the potential
for cross contamination
with penicillin.
Penicillin Cross
Contamination: All lots of
all products repackaged
and distributed between
01/05/12 and 02/12/15
are being recalled
because they were
repackaged in a facility
with penicillin products
without adequate
separation which could
introduce the potential
for cross contamination
with penicillin.
Penicillin Cross
Contamination: All lots of
all products repackaged
and distributed between
01/05/12 and 02/12/15
are being recalled
because they were
repackaged in a facility
with penicillin products
without adequate
separation which could
introduce the potential
for cross contamination
with penicillin.
Stability Data Does Not
Support Expiry: All lots of
all products repackaged
and distributed between
01/05/12 and 02/12/15
are being recalled
because they were
Recalling firm
Attix
Pharmaceutic
als
Attix
Pharmaceutic
als
Attix
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als
139
Product
Type
Product
Description
drums
Code info.
Class
Drugs
Piroxicam active
pharmaceutical
ingredient
packaged in
varying grams or
kg in bags or
drums
All lots
Class II
repackaged
and distributed
between
01/05/12 to
02/12/15
Drugs
Podophyllum
Resin active
pharmaceutical
ingredient
packaged in
varying grams or
kg in bags or
drums
All lots
Class II
repackaged
and distributed
between
01/05/12 to
02/12/15
Drugs
Polidocanol
active
pharmaceutical
ingredient
packaged in
varying grams or
kg in bags or
drums
All lots
Class II
repackaged
and distributed
between
01/05/12 to
02/12/15
Copyright© PerformRx, LLC 2015 All Rights Reserved
Reason for Recall
repackaged without data
to support the printed
expiry date.
Penicillin Cross
Contamination: All lots of
all products repackaged
and distributed between
01/05/12 and 02/12/15
are being recalled
because they were
repackaged in a facility
with penicillin products
without adequate
separation which could
introduce the potential
for cross contamination
with penicillin.
Penicillin Cross
Contamination: All lots of
all products repackaged
and distributed between
01/05/12 and 02/12/15
are being recalled
because they were
repackaged in a facility
with penicillin products
without adequate
separation which could
introduce the potential
for cross contamination
with penicillin.
Penicillin Cross
Contamination: All lots of
all products repackaged
and distributed between
01/05/12 and 02/12/15
are being recalled
because they were
repackaged in a facility
with penicillin products
without adequate
Recalling firm
Attix
Pharmaceutic
als
Attix
Pharmaceutic
als
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als
140
Product
Type
Product
Description
Code info.
Class
Drugs
Polidocanol
(Industrial Grade)
active
pharmaceutical
ingredient
packaged in
varying grams or
kg in bags or
drums
All lots
Class II
repackaged
and distributed
between
01/05/12 to
02/12/15
Drugs
Potassium
Acetate active
pharmaceutical
ingredient
packaged in
varying grams or
kg in bags or
drums
All lots
Class II
repackaged
and distributed
between
01/05/12 to
02/12/15
Drugs
Potassium
Chloride active
pharmaceutical
ingredient
packaged in
varying grams or
kg in bags or
drums
All lots
Class II
repackaged
and distributed
between
01/05/12 to
02/12/15
Copyright© PerformRx, LLC 2015 All Rights Reserved
Reason for Recall
separation which could
introduce the potential
for cross contamination
with penicillin.
Penicillin Cross
Contamination: All lots of
all products repackaged
and distributed between
01/05/12 and 02/12/15
are being recalled
because they were
repackaged in a facility
with penicillin products
without adequate
separation which could
introduce the potential
for cross contamination
with penicillin.
Penicillin Cross
Contamination: All lots of
all products repackaged
and distributed between
01/05/12 and 02/12/15
are being recalled
because they were
repackaged in a facility
with penicillin products
without adequate
separation which could
introduce the potential
for cross contamination
with penicillin.
Penicillin Cross
Contamination: All lots of
all products repackaged
and distributed between
01/05/12 and 02/12/15
are being recalled
because they were
repackaged in a facility
with penicillin products
Recalling firm
Attix
Pharmaceutic
als
Attix
Pharmaceutic
als
Attix
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als
141
Product
Type
Product
Description
Code info.
Class
Drugs
Potassium
Phosphate
Monobasic
pharmaceutical
ingredient
packaged in
varying grams or
kg in bags or
drums
All lots
Class II
repackaged
and distributed
between
01/05/12 to
02/12/15
Drugs
Povidone K-30
pharmaceutical
ingredient
packaged in
varying grams or
kg in bags or
drums
All lots
Class II
repackaged
and distributed
between
01/05/12 to
02/12/15
Drugs
Pralidoxime
Chloride active
pharmaceutical
ingredient
packaged in
varying grams or
kg in bags or
drums
All lots
Class II
repackaged
and distributed
between
01/05/12 to
02/12/15
Copyright© PerformRx, LLC 2015 All Rights Reserved
Reason for Recall
without adequate
separation which could
introduce the potential
for cross contamination
with penicillin.
Penicillin Cross
Contamination: All lots of
all products repackaged
and distributed between
01/05/12 and 02/12/15
are being recalled
because they were
repackaged in a facility
with penicillin products
without adequate
separation which could
introduce the potential
for cross contamination
with penicillin.
Penicillin Cross
Contamination: All lots of
all products repackaged
and distributed between
01/05/12 and 02/12/15
are being recalled
because they were
repackaged in a facility
with penicillin products
without adequate
separation which could
introduce the potential
for cross contamination
with penicillin.
Penicillin Cross
Contamination: All lots of
all products repackaged
and distributed between
01/05/12 and 02/12/15
are being recalled
because they were
repackaged in a facility
Recalling firm
Attix
Pharmaceutic
als
Attix
Pharmaceutic
als
Attix
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als
142
Product
Type
Product
Description
Code info.
Class
Drugs
Prazosin HCl
active
pharmaceutical
ingredient
packaged in
varying grams or
kg in bags or
drums
All lots
Class II
repackaged
and distributed
between
01/05/12 to
02/12/15
Drugs
Prednisolone
Acetate active
pharmaceutical
ingredient
packaged in
varying grams or
kg in bags or
drums
All lots
Class II
repackaged
and distributed
between
01/05/12 to
02/12/15
Drugs
Prednisolone
Anhydrous active
pharmaceutical
ingredient
packaged in
varying grams or
kg in bags or
All lots
Class II
repackaged
and distributed
between
01/05/12 to
02/12/15
Copyright© PerformRx, LLC 2015 All Rights Reserved
Reason for Recall
with penicillin products
without adequate
separation which could
introduce the potential
for cross contamination
with penicillin.
Penicillin Cross
Contamination: All lots of
all products repackaged
and distributed between
01/05/12 and 02/12/15
are being recalled
because they were
repackaged in a facility
with penicillin products
without adequate
separation which could
introduce the potential
for cross contamination
with penicillin.
Penicillin Cross
Contamination: All lots of
all products repackaged
and distributed between
01/05/12 and 02/12/15
are being recalled
because they were
repackaged in a facility
with penicillin products
without adequate
separation which could
introduce the potential
for cross contamination
with penicillin.
Penicillin Cross
Contamination: All lots of
all products repackaged
and distributed between
01/05/12 and 02/12/15
are being recalled
because they were
Recalling firm
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143
Product
Type
Product
Description
drums
Code info.
Class
Drugs
Prednisolone
Anhydrous
Micronized active
pharmaceutical
ingredient
packaged in
varying grams or
kg in bags or
drums
All lots
Class II
repackaged
and distributed
between
01/05/12 to
02/12/15
Drugs
Prednisone active
pharmaceutical
ingredient
packaged in
varying grams or
kg in bags or
drums
All lots
Class II
repackaged
and distributed
between
01/05/12 to
02/12/15
Drugs
Pregabalin active
pharmaceutical
ingredient
packaged in
varying grams or
kg in bags or
All lots
Class II
repackaged
and distributed
between
01/05/12 to
02/12/15
Copyright© PerformRx, LLC 2015 All Rights Reserved
Reason for Recall
repackaged in a facility
with penicillin products
without adequate
separation which could
introduce the potential
for cross contamination
with penicillin.
Penicillin Cross
Contamination: All lots of
all products repackaged
and distributed between
01/05/12 and 02/12/15
are being recalled
because they were
repackaged in a facility
with penicillin products
without adequate
separation which could
introduce the potential
for cross contamination
with penicillin.
Penicillin Cross
Contamination: All lots of
all products repackaged
and distributed between
01/05/12 and 02/12/15
are being recalled
because they were
repackaged in a facility
with penicillin products
without adequate
separation which could
introduce the potential
for cross contamination
with penicillin.
Penicillin Cross
Contamination: All lots of
all products repackaged
and distributed between
01/05/12 and 02/12/15
are being recalled
Recalling firm
Attix
Pharmaceutic
als
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als
144
Product
Type
Product
Description
drums
Code info.
Class
Drugs
Pregelatinized
Starch
pharmaceutical
ingredient
packaged in
varying grams or
kg in bags or
drums
All lots
Class II
repackaged
and distributed
between
01/05/12 to
02/12/15
Drugs
Prilocaine HCl
active
pharmaceutical
ingredient
packaged in
varying grams or
kg in bags or
drums
All lots
Class II
repackaged
and distributed
between
01/05/12 to
02/12/15
Drugs
Primaquine
Phosphate active
pharmaceutical
ingredient
packaged in
All lots
Class II
repackaged
and distributed
between
01/05/12 to
Copyright© PerformRx, LLC 2015 All Rights Reserved
Reason for Recall
because they were
repackaged in a facility
with penicillin products
without adequate
separation which could
introduce the potential
for cross contamination
with penicillin.
Penicillin Cross
Contamination: All lots of
all products repackaged
and distributed between
01/05/12 and 02/12/15
are being recalled
because they were
repackaged in a facility
with penicillin products
without adequate
separation which could
introduce the potential
for cross contamination
with penicillin.
Penicillin Cross
Contamination: All lots of
all products repackaged
and distributed between
01/05/12 and 02/12/15
are being recalled
because they were
repackaged in a facility
with penicillin products
without adequate
separation which could
introduce the potential
for cross contamination
with penicillin.
Penicillin Cross
Contamination: All lots of
all products repackaged
and distributed between
01/05/12 and 02/12/15
Recalling firm
Attix
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145
Product
Type
Product
Description
varying grams or
kg in bags or
drums
Code info.
Class
Drugs
Procainamide HCl
active
pharmaceutical
ingredient
packaged in
varying grams or
kg in bags or
drums
All lots
Class II
repackaged
and distributed
between
01/05/12 to
02/12/15
Drugs
Procaine HCl
active
pharmaceutical
ingredient
packaged in
varying grams or
kg in bags or
drums
All lots
Class II
repackaged
and distributed
between
01/05/12 to
02/12/15
Drugs
Procaine
Penicillin G active
pharmaceutical
ingredient
All lots
Class II
repackaged
and distributed
between
02/12/15
Copyright© PerformRx, LLC 2015 All Rights Reserved
Reason for Recall
are being recalled
because they were
repackaged in a facility
with penicillin products
without adequate
separation which could
introduce the potential
for cross contamination
with penicillin.
Penicillin Cross
Contamination: All lots of
all products repackaged
and distributed between
01/05/12 and 02/12/15
are being recalled
because they were
repackaged in a facility
with penicillin products
without adequate
separation which could
introduce the potential
for cross contamination
with penicillin.
Penicillin Cross
Contamination: All lots of
all products repackaged
and distributed between
01/05/12 and 02/12/15
are being recalled
because they were
repackaged in a facility
with penicillin products
without adequate
separation which could
introduce the potential
for cross contamination
with penicillin.
Stability Data Does Not
Support Expiry: All lots of
all products repackaged
and distributed between
Recalling firm
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146
Product
Type
Product
Description
packaged in
varying grams or
kg in bags or
drums
Code info.
Class
Drugs
Procarbazine HCl
active
pharmaceutical
ingredient
packaged in
varying grams or
kg in bags or
drums
All lots
Class II
repackaged
and distributed
between
01/05/12 to
02/12/15
Drugs
Progesterone
active
pharmaceutical
ingredient
packaged in
varying grams or
kg in bags or
drums
All lots
Class II
repackaged
and distributed
between
01/05/12 to
02/12/15
Drugs
Progesterone Soy
Source active
pharmaceutical
ingredient
packaged in
varying grams or
kg in bags or
All lots
Class II
repackaged
and distributed
between
01/05/12 to
02/12/15
01/05/12 to
02/12/15
Copyright© PerformRx, LLC 2015 All Rights Reserved
Reason for Recall
01/05/12 and 02/12/15
are being recalled
because they were
repackaged without data
to support the printed
expiry date.
Penicillin Cross
Contamination: All lots of
all products repackaged
and distributed between
01/05/12 and 02/12/15
are being recalled
because they were
repackaged in a facility
with penicillin products
without adequate
separation which could
introduce the potential
for cross contamination
with penicillin.
Penicillin Cross
Contamination: All lots of
all products repackaged
and distributed between
01/05/12 and 02/12/15
are being recalled
because they were
repackaged in a facility
with penicillin products
without adequate
separation which could
introduce the potential
for cross contamination
with penicillin.
Penicillin Cross
Contamination: All lots of
all products repackaged
and distributed between
01/05/12 and 02/12/15
are being recalled
because they were
Recalling firm
Attix
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als
147
Product
Type
Product
Description
drums
Code info.
Class
Drugs
Progesterone
Ultra-Micronized
active
pharmaceutical
ingredient
packaged in
varying grams or
kg in bags or
drums
All lots
Class II
repackaged
and distributed
between
01/05/12 to
02/12/15
Drugs
Proparacaine HCl
active
pharmaceutical
ingredient
packaged in
varying grams or
kg in bags or
drums
All lots
Class II
repackaged
and distributed
between
01/05/12 to
02/12/15
Drugs
Pyrazinamide
active
pharmaceutical
ingredient
packaged in
varying grams or
All lots
Class II
repackaged
and distributed
between
01/05/12 to
02/12/15
Copyright© PerformRx, LLC 2015 All Rights Reserved
Reason for Recall
repackaged in a facility
with penicillin products
without adequate
separation which could
introduce the potential
for cross contamination
with penicillin.
Penicillin Cross
Contamination: All lots of
all products repackaged
and distributed between
01/05/12 and 02/12/15
are being recalled
because they were
repackaged in a facility
with penicillin products
without adequate
separation which could
introduce the potential
for cross contamination
with penicillin.
Penicillin Cross
Contamination: All lots of
all products repackaged
and distributed between
01/05/12 and 02/12/15
are being recalled
because they were
repackaged in a facility
with penicillin products
without adequate
separation which could
introduce the potential
for cross contamination
with penicillin.
Penicillin Cross
Contamination: All lots of
all products repackaged
and distributed between
01/05/12 and 02/12/15
are being recalled
Recalling firm
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als
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als
148
Product
Type
Product
Description
kg in bags or
drums
Code info.
Class
Drugs
Pyridostigmine
Bromide active
pharmaceutical
ingredient
packaged in
varying grams or
kg in bags or
drums
All lots
Class II
repackaged
and distributed
between
01/05/12 to
02/12/15
Drugs
Quetiapine
Fumarate active
pharmaceutical
ingredient
packaged in
varying grams or
kg in bags or
drums
All lots
Class II
repackaged
and distributed
between
01/05/12 to
02/12/15
Drugs
Quinine Sulfate
Dihydrate active
pharmaceutical
ingredient
packaged in
All lots
Class II
repackaged
and distributed
between
01/05/12 to
Copyright© PerformRx, LLC 2015 All Rights Reserved
Reason for Recall
because they were
repackaged in a facility
with penicillin products
without adequate
separation which could
introduce the potential
for cross contamination
with penicillin.
Penicillin Cross
Contamination: All lots of
all products repackaged
and distributed between
01/05/12 and 02/12/15
are being recalled
because they were
repackaged in a facility
with penicillin products
without adequate
separation which could
introduce the potential
for cross contamination
with penicillin.
Penicillin Cross
Contamination: All lots of
all products repackaged
and distributed between
01/05/12 and 02/12/15
are being recalled
because they were
repackaged in a facility
with penicillin products
without adequate
separation which could
introduce the potential
for cross contamination
with penicillin.
Penicillin Cross
Contamination: All lots of
all products repackaged
and distributed between
01/05/12 and 02/12/15
Recalling firm
Attix
Pharmaceutic
als
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Pharmaceutic
als
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als
149
Product
Type
Product
Description
varying grams or
kg in bags or
drums
Code info.
Class
Drugs
Ranitidine HCl
active
pharmaceutical
ingredient
packaged in
varying grams or
kg in bags or
drums
All lots
Class II
repackaged
and distributed
between
01/05/12 to
02/12/15
Drugs
Rebamipide
active
pharmaceutical
ingredient
packaged in
varying grams or
kg in bags or
drums
All lots
Class II
repackaged
and distributed
between
01/05/12 to
02/12/15
Drugs
Reserpine active
pharmaceutical
ingredient
packaged in
All lots
Class II
repackaged
and distributed
between
02/12/15
Copyright© PerformRx, LLC 2015 All Rights Reserved
Reason for Recall
are being recalled
because they were
repackaged in a facility
with penicillin products
without adequate
separation which could
introduce the potential
for cross contamination
with penicillin.
Penicillin Cross
Contamination: All lots of
all products repackaged
and distributed between
01/05/12 and 02/12/15
are being recalled
because they were
repackaged in a facility
with penicillin products
without adequate
separation which could
introduce the potential
for cross contamination
with penicillin.
Penicillin Cross
Contamination: All lots of
all products repackaged
and distributed between
01/05/12 and 02/12/15
are being recalled
because they were
repackaged in a facility
with penicillin products
without adequate
separation which could
introduce the potential
for cross contamination
with penicillin.
Penicillin Cross
Contamination: All lots of
all products repackaged
and distributed between
Recalling firm
Attix
Pharmaceutic
als
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als
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als
150
Product
Type
Product
Description
varying grams or
kg in bags or
drums
Code info.
Class
Drugs
Retinoic Acid
active
pharmaceutical
ingredient
packaged in
varying grams or
kg in bags or
drums
All lots
Class II
repackaged
and distributed
between
01/05/12 to
02/12/15
Drugs
Ribavirin active
pharmaceutical
ingredient
packaged in
varying grams or
kg in bags or
drums
All lots
Class II
repackaged
and distributed
between
01/05/12 to
02/12/15
Drugs
Rifaximin active
pharmaceutical
ingredient
All lots
Class II
repackaged
and distributed
01/05/12 to
02/12/15
Copyright© PerformRx, LLC 2015 All Rights Reserved
Reason for Recall
01/05/12 and 02/12/15
are being recalled
because they were
repackaged in a facility
with penicillin products
without adequate
separation which could
introduce the potential
for cross contamination
with penicillin.
Penicillin Cross
Contamination: All lots of
all products repackaged
and distributed between
01/05/12 and 02/12/15
are being recalled
because they were
repackaged in a facility
with penicillin products
without adequate
separation which could
introduce the potential
for cross contamination
with penicillin.
Penicillin Cross
Contamination: All lots of
all products repackaged
and distributed between
01/05/12 and 02/12/15
are being recalled
because they were
repackaged in a facility
with penicillin products
without adequate
separation which could
introduce the potential
for cross contamination
with penicillin.
Penicillin Cross
Contamination: All lots of
all products repackaged
Recalling firm
Attix
Pharmaceutic
als
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als
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als
151
Product
Type
Product
Description
packaged in
varying grams or
kg in bags or
drums
Code info.
Class
Drugs
Ritonavir active
pharmaceutical
ingredient
packaged in
varying grams or
kg in bags or
drums
All lots
Class II
repackaged
and distributed
between
01/05/12 to
02/12/15
Drugs
Rivaroxaban
active
pharmaceutical
ingredient
packaged in
varying grams or
kg in bags or
drums
All lots
Class II
repackaged
and distributed
between
01/05/12 to
02/12/15
Drugs
Rocuronium
Bromide active
All lots
repackaged
between
01/05/12 to
02/12/15
Class II
Copyright© PerformRx, LLC 2015 All Rights Reserved
Reason for Recall
and distributed between
01/05/12 and 02/12/15
are being recalled
because they were
repackaged in a facility
with penicillin products
without adequate
separation which could
introduce the potential
for cross contamination
with penicillin.
Penicillin Cross
Contamination: All lots of
all products repackaged
and distributed between
01/05/12 and 02/12/15
are being recalled
because they were
repackaged in a facility
with penicillin products
without adequate
separation which could
introduce the potential
for cross contamination
with penicillin.
Penicillin Cross
Contamination: All lots of
all products repackaged
and distributed between
01/05/12 and 02/12/15
are being recalled
because they were
repackaged in a facility
with penicillin products
without adequate
separation which could
introduce the potential
for cross contamination
with penicillin.
Penicillin Cross
Contamination: All lots of
Recalling firm
Attix
Pharmaceutic
als
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Pharmaceutic
als
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Pharmaceutic
152
Product
Type
Product
Description
pharmaceutical
ingredient
packaged in
varying grams or
kg in bags or
drums
Code info.
Class
Drugs
Roflumilast active
pharmaceutical
ingredient
packaged in
varying grams or
kg in bags or
drums
All lots
Class II
repackaged
and distributed
between
01/05/12 to
02/12/15
Drugs
Ropivacaine HCl
active
pharmaceutical
ingredient
packaged in
varying grams or
kg in bags or
drums
All lots
Class II
repackaged
and distributed
between
01/05/12 to
02/12/15
Drugs
Roxithromycin
All lots
and distributed
between
01/05/12 to
02/12/15
Class II
Copyright© PerformRx, LLC 2015 All Rights Reserved
Reason for Recall
Recalling firm
all products repackaged
and distributed between
01/05/12 and 02/12/15
are being recalled
because they were
repackaged in a facility
with penicillin products
without adequate
separation which could
introduce the potential
for cross contamination
with penicillin.
Penicillin Cross
Contamination: All lots of
all products repackaged
and distributed between
01/05/12 and 02/12/15
are being recalled
because they were
repackaged in a facility
with penicillin products
without adequate
separation which could
introduce the potential
for cross contamination
with penicillin.
Penicillin Cross
Contamination: All lots of
all products repackaged
and distributed between
01/05/12 and 02/12/15
are being recalled
because they were
repackaged in a facility
with penicillin products
without adequate
separation which could
introduce the potential
for cross contamination
with penicillin.
Penicillin Cross
als
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als
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Pharmaceutic
als
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153
Product
Type
Product
Description
active
pharmaceutical
ingredient
packaged in
varying grams or
kg in bags or
drums
Code info.
Class
Drugs
Satraplatin active
pharmaceutical
ingredient
packaged in
varying grams or
kg in bags or
drums
All lots
Class II
repackaged
and distributed
between
01/05/12 to
02/12/15
Drugs
Secnidazole
active
pharmaceutical
ingredient
packaged in
varying grams or
kg in bags or
drums
All lots
Class II
repackaged
and distributed
between
01/05/12 to
02/12/15
repackaged
and distributed
between
01/05/12 to
02/12/15
Copyright© PerformRx, LLC 2015 All Rights Reserved
Reason for Recall
Recalling firm
Contamination: All lots of
all products repackaged
and distributed between
01/05/12 and 02/12/15
are being recalled
because they were
repackaged in a facility
with penicillin products
without adequate
separation which could
introduce the potential
for cross contamination
with penicillin.
Penicillin Cross
Contamination: All lots of
all products repackaged
and distributed between
01/05/12 and 02/12/15
are being recalled
because they were
repackaged in a facility
with penicillin products
without adequate
separation which could
introduce the potential
for cross contamination
with penicillin.
Penicillin Cross
Contamination: All lots of
all products repackaged
and distributed between
01/05/12 and 02/12/15
are being recalled
because they were
repackaged in a facility
with penicillin products
without adequate
separation which could
introduce the potential
for cross contamination
with penicillin.
Pharmaceutic
als
Attix
Pharmaceutic
als
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als
154
Product
Type
Drugs
Product
Description
Secretin Acetate
active
pharmaceutical
ingredient
packaged in
varying grams or
kg in bags or
drums
Code info.
Class
Drugs
Seratonin HCl
active
pharmaceutical
ingredient
packaged in
varying grams or
kg in bags or
drums
All lots
Class II
repackaged
and distributed
between
01/05/12 to
02/12/15
Drugs
Sertraline HCl
active
pharmaceutical
ingredient
packaged in
varying grams or
kg in bags or
drums
All lots
Class II
repackaged
and distributed
between
01/05/12 to
02/12/15
All lots
Class II
repackaged
and distributed
between
01/05/12 to
02/12/15
Copyright© PerformRx, LLC 2015 All Rights Reserved
Reason for Recall
Recalling firm
Penicillin Cross
Contamination: All lots of
all products repackaged
and distributed between
01/05/12 and 02/12/15
are being recalled
because they were
repackaged in a facility
with penicillin products
without adequate
separation which could
introduce the potential
for cross contamination
with penicillin.
Penicillin Cross
Contamination: All lots of
all products repackaged
and distributed between
01/05/12 and 02/12/15
are being recalled
because they were
repackaged in a facility
with penicillin products
without adequate
separation which could
introduce the potential
for cross contamination
with penicillin.
Penicillin Cross
Contamination: All lots of
all products repackaged
and distributed between
01/05/12 and 02/12/15
are being recalled
because they were
repackaged in a facility
with penicillin products
without adequate
separation which could
introduce the potential
for cross contamination
Attix
Pharmaceutic
als
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als
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als
155
Product
Type
Product
Description
Code info.
Class
Drugs
Sevelamer HCl
active
pharmaceutical
ingredient
packaged in
varying grams or
kg in bags or
drums
All lots
Class II
repackaged
and distributed
between
01/05/12 to
02/12/15
Drugs
Sildenafil Citrate
active
pharmaceutical
ingredient
packaged in
varying grams or
kg in bags or
drums
All lots
Class II
repackaged
and distributed
between
01/05/12 to
02/12/15
Drugs
Silver Sulfadiazine
active
pharmaceutical
ingredient
packaged in
varying grams or
kg in bags or
drums
All lots
Class II
repackaged
and distributed
between
01/05/12 to
02/12/15
Copyright© PerformRx, LLC 2015 All Rights Reserved
Reason for Recall
with penicillin.
Penicillin Cross
Contamination: All lots of
all products repackaged
and distributed between
01/05/12 and 02/12/15
are being recalled
because they were
repackaged in a facility
with penicillin products
without adequate
separation which could
introduce the potential
for cross contamination
with penicillin.
Penicillin Cross
Contamination: All lots of
all products repackaged
and distributed between
01/05/12 and 02/12/15
are being recalled
because they were
repackaged in a facility
with penicillin products
without adequate
separation which could
introduce the potential
for cross contamination
with penicillin.
Penicillin Cross
Contamination: All lots of
all products repackaged
and distributed between
01/05/12 and 02/12/15
are being recalled
because they were
repackaged in a facility
with penicillin products
without adequate
separation which could
introduce the potential
Recalling firm
Attix
Pharmaceutic
als
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als
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als
156
Product
Type
Product
Description
Code info.
Class
Drugs
Simvastatin
active
pharmaceutical
ingredient
packaged in
varying grams or
kg in bags or
drums
All lots
Class II
repackaged
and distributed
between
01/05/12 to
02/12/15
Drugs
Sirlolimus active
pharmaceutical
ingredient
packaged in
varying grams or
kg in bags or
drums
All lots
Class II
repackaged
and distributed
between
01/05/12 to
02/12/15
Drugs
Sodium
Dichloroacetate
active
pharmaceutical
ingredient
packaged in
varying grams or
kg in bags or
drums
All lots
Class II
repackaged
and distributed
between
01/05/12 to
02/12/15
Copyright© PerformRx, LLC 2015 All Rights Reserved
Reason for Recall
for cross contamination
with penicillin.
Penicillin Cross
Contamination: All lots of
all products repackaged
and distributed between
01/05/12 and 02/12/15
are being recalled
because they were
repackaged in a facility
with penicillin products
without adequate
separation which could
introduce the potential
for cross contamination
with penicillin.
Penicillin Cross
Contamination: All lots of
all products repackaged
and distributed between
01/05/12 and 02/12/15
are being recalled
because they were
repackaged in a facility
with penicillin products
without adequate
separation which could
introduce the potential
for cross contamination
with penicillin.
Penicillin Cross
Contamination: All lots of
all products repackaged
and distributed between
01/05/12 and 02/12/15
are being recalled
because they were
repackaged in a facility
with penicillin products
without adequate
separation which could
Recalling firm
Attix
Pharmaceutic
als
Attix
Pharmaceutic
als
Attix
Pharmaceutic
als
157
Product
Type
Product
Description
Code info.
Class
Drugs
Sodium
Gluconate active
pharmaceutical
ingredient
packaged in
varying grams or
kg in bags or
drums
All lots
Class II
repackaged
and distributed
between
01/05/12 to
02/12/15
Drugs
Sodium Iodide
active
pharmaceutical
ingredient
packaged in
varying grams or
kg in bags or
drums
All lots
Class II
repackaged
and distributed
between
01/05/12 to
02/12/15
Drugs
Sodium
Phenylbutyrate
active
pharmaceutical
ingredient
packaged in
varying grams or
kg in bags or
drums
All lots
Class II
repackaged
and distributed
between
01/05/12 to
02/12/15
Copyright© PerformRx, LLC 2015 All Rights Reserved
Reason for Recall
introduce the potential
for cross contamination
with penicillin.
Penicillin Cross
Contamination: All lots of
all products repackaged
and distributed between
01/05/12 and 02/12/15
are being recalled
because they were
repackaged in a facility
with penicillin products
without adequate
separation which could
introduce the potential
for cross contamination
with penicillin.
Penicillin Cross
Contamination: All lots of
all products repackaged
and distributed between
01/05/12 and 02/12/15
are being recalled
because they were
repackaged in a facility
with penicillin products
without adequate
separation which could
introduce the potential
for cross contamination
with penicillin.
Penicillin Cross
Contamination: All lots of
all products repackaged
and distributed between
01/05/12 and 02/12/15
are being recalled
because they were
repackaged in a facility
with penicillin products
without adequate
Recalling firm
Attix
Pharmaceutic
als
Attix
Pharmaceutic
als
Attix
Pharmaceutic
als
158
Product
Type
Product
Description
Code info.
Class
Drugs
Sodium Starch
Glycolate
pharmaceutical
ingredient
packaged in
varying grams or
kg in bags or
drums
All lots
Class II
repackaged
and distributed
between
01/05/12 to
02/12/15
Drugs
Sorafenib active
pharmaceutical
ingredient
packaged in
varying grams or
kg in bags or
drums
All lots
Class II
repackaged
and distributed
between
01/05/12 to
02/12/15
Drugs
Spectinomycin
Sulfate active
pharmaceutical
ingredient
packaged in
varying grams or
kg in bags or
drums
All lots
Class II
repackaged
and distributed
between
01/05/12 to
02/12/15
Copyright© PerformRx, LLC 2015 All Rights Reserved
Reason for Recall
separation which could
introduce the potential
for cross contamination
with penicillin.
Penicillin Cross
Contamination: All lots of
all products repackaged
and distributed between
01/05/12 and 02/12/15
are being recalled
because they were
repackaged in a facility
with penicillin products
without adequate
separation which could
introduce the potential
for cross contamination
with penicillin.
Penicillin Cross
Contamination: All lots of
all products repackaged
and distributed between
01/05/12 and 02/12/15
are being recalled
because they were
repackaged in a facility
with penicillin products
without adequate
separation which could
introduce the potential
for cross contamination
with penicillin.
Penicillin Cross
Contamination: All lots of
all products repackaged
and distributed between
01/05/12 and 02/12/15
are being recalled
because they were
repackaged in a facility
with penicillin products
Recalling firm
Attix
Pharmaceutic
als
Attix
Pharmaceutic
als
Attix
Pharmaceutic
als
159
Product
Type
Product
Description
Code info.
Class
Drugs
Streptomycin
Sulfate or
Sulphate active
pharmaceutical
ingredient
packaged in
varying grams or
kg in bags or
drums
All lots
Class II
repackaged
and distributed
between
01/05/12 to
02/12/15
Drugs
Sucralfate active
pharmaceutical
ingredient
packaged in
varying grams or
kg in bags or
drums
All lots
Class II
repackaged
and distributed
between
01/05/12 to
02/12/15
Drugs
Sulfanilamide
active
pharmaceutical
ingredient
packaged in
varying grams or
kg in bags or
drums
All lots
Class II
repackaged
and distributed
between
01/05/12 to
02/12/15
Copyright© PerformRx, LLC 2015 All Rights Reserved
Reason for Recall
without adequate
separation which could
introduce the potential
for cross contamination
with penicillin.
Penicillin Cross
Contamination: All lots of
all products repackaged
and distributed between
01/05/12 and 02/12/15
are being recalled
because they were
repackaged in a facility
with penicillin products
without adequate
separation which could
introduce the potential
for cross contamination
with penicillin.
Penicillin Cross
Contamination: All lots of
all products repackaged
and distributed between
01/05/12 and 02/12/15
are being recalled
because they were
repackaged in a facility
with penicillin products
without adequate
separation which could
introduce the potential
for cross contamination
with penicillin.
Penicillin Cross
Contamination: All lots of
all products repackaged
and distributed between
01/05/12 and 02/12/15
are being recalled
because they were
repackaged in a facility
Recalling firm
Attix
Pharmaceutic
als
Attix
Pharmaceutic
als
Attix
Pharmaceutic
als
160
Product
Type
Product
Description
Code info.
Class
Drugs
Sulfathiazole
active
pharmaceutical
ingredient
packaged in
varying grams or
kg in bags or
drums
All lots
Class II
repackaged
and distributed
between
01/05/12 to
02/12/15
Drugs
Sulphafurazole
(Sulfisoxazole)
active
pharmaceutical
ingredient
packaged in
varying grams or
kg in bags or
drums
All lots
Class II
repackaged
and distributed
between
01/05/12 to
02/12/15
Drugs
Sumatriptan
Succinate active
pharmaceutical
ingredient
packaged in
varying grams or
kg in bags or
All lots
Class II
repackaged
and distributed
between
01/05/12 to
02/12/15
Copyright© PerformRx, LLC 2015 All Rights Reserved
Reason for Recall
with penicillin products
without adequate
separation which could
introduce the potential
for cross contamination
with penicillin.
Penicillin Cross
Contamination: All lots of
all products repackaged
and distributed between
01/05/12 and 02/12/15
are being recalled
because they were
repackaged in a facility
with penicillin products
without adequate
separation which could
introduce the potential
for cross contamination
with penicillin.
Penicillin Cross
Contamination: All lots of
all products repackaged
and distributed between
01/05/12 and 02/12/15
are being recalled
because they were
repackaged in a facility
with penicillin products
without adequate
separation which could
introduce the potential
for cross contamination
with penicillin.
Penicillin Cross
Contamination: All lots of
all products repackaged
and distributed between
01/05/12 and 02/12/15
are being recalled
because they were
Recalling firm
Attix
Pharmaceutic
als
Attix
Pharmaceutic
als
Attix
Pharmaceutic
als
161
Product
Type
Product
Description
drums
Code info.
Class
Drugs
Tacrolimus
Monohydrate
active
pharmaceutical
ingredient
packaged in
varying grams or
kg in bags or
drums
All lots
Class II
repackaged
and distributed
between
01/05/12 to
02/12/15
Drugs
Tadalafil active
pharmaceutical
ingredient
packaged in
varying grams or
kg in bags or
drums
All lots
Class II
repackaged
and distributed
between
01/05/12 to
02/12/15
Drugs
Tadalafil Citrate
active
pharmaceutical
ingredient
packaged in
varying grams or
All lots
Class II
repackaged
and distributed
between
01/05/12 to
02/12/15
Copyright© PerformRx, LLC 2015 All Rights Reserved
Reason for Recall
repackaged in a facility
with penicillin products
without adequate
separation which could
introduce the potential
for cross contamination
with penicillin.
Penicillin Cross
Contamination: All lots of
all products repackaged
and distributed between
01/05/12 and 02/12/15
are being recalled
because they were
repackaged in a facility
with penicillin products
without adequate
separation which could
introduce the potential
for cross contamination
with penicillin.
Penicillin Cross
Contamination: All lots of
all products repackaged
and distributed between
01/05/12 and 02/12/15
are being recalled
because they were
repackaged in a facility
with penicillin products
without adequate
separation which could
introduce the potential
for cross contamination
with penicillin.
Penicillin Cross
Contamination: All lots of
all products repackaged
and distributed between
01/05/12 and 02/12/15
are being recalled
Recalling firm
Attix
Pharmaceutic
als
Attix
Pharmaceutic
als
Attix
Pharmaceutic
als
162
Product
Type
Product
Description
kg in bags or
drums
Code info.
Class
Drugs
Tamoxifen Citrate
active
pharmaceutical
ingredient
packaged in
varying grams or
kg in bags or
drums
All lots
Class II
repackaged
and distributed
between
01/05/12 to
02/12/15
Drugs
Tamsulosin Base
active
pharmaceutical
ingredient
packaged in
varying grams or
kg in bags or
drums
All lots
Class II
repackaged
and distributed
between
01/05/12 to
02/12/15
Drugs
Taurolidine active
pharmaceutical
ingredient
packaged in
varying grams or
All lots
Class II
repackaged
and distributed
between
01/05/12 to
Copyright© PerformRx, LLC 2015 All Rights Reserved
Reason for Recall
because they were
repackaged in a facility
with penicillin products
without adequate
separation which could
introduce the potential
for cross contamination
with penicillin.
Penicillin Cross
Contamination: All lots of
all products repackaged
and distributed between
01/05/12 and 02/12/15
are being recalled
because they were
repackaged in a facility
with penicillin products
without adequate
separation which could
introduce the potential
for cross contamination
with penicillin.
Penicillin Cross
Contamination: All lots of
all products repackaged
and distributed between
01/05/12 and 02/12/15
are being recalled
because they were
repackaged in a facility
with penicillin products
without adequate
separation which could
introduce the potential
for cross contamination
with penicillin.
Penicillin Cross
Contamination: All lots of
all products repackaged
and distributed between
01/05/12 and 02/12/15
Recalling firm
Attix
Pharmaceutic
als
Attix
Pharmaceutic
als
Attix
Pharmaceutic
als
163
Product
Type
Product
Description
kg in bags or
drums
Code info.
Class
Drugs
Tegaserod
Maleate active
pharmaceutical
ingredient
packaged in
varying grams or
kg in bags or
drums
All lots
Class II
repackaged
and distributed
between
01/05/12 to
02/12/15
Drugs
Telaprevir active
pharmaceutical
ingredient
packaged in
varying grams or
kg in bags or
drums
All lots
Class II
repackaged
and distributed
between
01/05/12 to
02/12/15
Drugs
Temozolomide
active
pharmaceutical
ingredient
All lots
Class II
repackaged
and distributed
between
02/12/15
Copyright© PerformRx, LLC 2015 All Rights Reserved
Reason for Recall
are being recalled
because they were
repackaged in a facility
with penicillin products
without adequate
separation which could
introduce the potential
for cross contamination
with penicillin.
Penicillin Cross
Contamination: All lots of
all products repackaged
and distributed between
01/05/12 and 02/12/15
are being recalled
because they were
repackaged in a facility
with penicillin products
without adequate
separation which could
introduce the potential
for cross contamination
with penicillin.
Penicillin Cross
Contamination: All lots of
all products repackaged
and distributed between
01/05/12 and 02/12/15
are being recalled
because they were
repackaged in a facility
with penicillin products
without adequate
separation which could
introduce the potential
for cross contamination
with penicillin.
Penicillin Cross
Contamination: All lots of
all products repackaged
and distributed between
Recalling firm
Attix
Pharmaceutic
als
Attix
Pharmaceutic
als
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als
164
Product
Type
Product
Description
packaged in
varying grams or
kg in bags or
drums
Code info.
Class
Drugs
Terbinafine active
pharmaceutical
ingredient
packaged in
varying grams or
kg in bags or
drums
All lots
Class II
repackaged
and distributed
between
01/05/12 to
02/12/15
Drugs
Terbinafine Base
active
pharmaceutical
ingredient
packaged in
varying grams or
kg in bags or
drums
All lots
Class II
repackaged
and distributed
between
01/05/12 to
02/12/15
Drugs
Terbinafine HCl
active
pharmaceutical
All lots
Class II
repackaged
and distributed
01/05/12 to
02/12/15
Copyright© PerformRx, LLC 2015 All Rights Reserved
Reason for Recall
01/05/12 and 02/12/15
are being recalled
because they were
repackaged in a facility
with penicillin products
without adequate
separation which could
introduce the potential
for cross contamination
with penicillin.
Penicillin Cross
Contamination: All lots of
all products repackaged
and distributed between
01/05/12 and 02/12/15
are being recalled
because they were
repackaged in a facility
with penicillin products
without adequate
separation which could
introduce the potential
for cross contamination
with penicillin.
Penicillin Cross
Contamination: All lots of
all products repackaged
and distributed between
01/05/12 and 02/12/15
are being recalled
because they were
repackaged in a facility
with penicillin products
without adequate
separation which could
introduce the potential
for cross contamination
with penicillin.
Penicillin Cross
Contamination: All lots of
all products repackaged
Recalling firm
Attix
Pharmaceutic
als
Attix
Pharmaceutic
als
Attix
Pharmaceutic
als
165
Product
Type
Product
Description
ingredient
packaged in
varying grams or
kg in bags or
drums
Code info.
Class
Drugs
Tetracaine (free
base) active
pharmaceutical
ingredient
packaged in
varying grams or
kg in bags or
drums
All lots
Class II
repackaged
and distributed
between
01/05/12 to
02/12/15
Drugs
Tetracaine HCl
active
pharmaceutical
ingredient
packaged in
varying grams or
kg in bags or
drums
All lots
Class II
repackaged
and distributed
between
01/05/12 to
02/12/15
Drugs
Tetracycline HCl
active
All lots
repackaged
between
01/05/12 to
02/12/15
Class II
Copyright© PerformRx, LLC 2015 All Rights Reserved
Reason for Recall
and distributed between
01/05/12 and 02/12/15
are being recalled
because they were
repackaged in a facility
with penicillin products
without adequate
separation which could
introduce the potential
for cross contamination
with penicillin.
Penicillin Cross
Contamination: All lots of
all products repackaged
and distributed between
01/05/12 and 02/12/15
are being recalled
because they were
repackaged in a facility
with penicillin products
without adequate
separation which could
introduce the potential
for cross contamination
with penicillin.
Penicillin Cross
Contamination: All lots of
all products repackaged
and distributed between
01/05/12 and 02/12/15
are being recalled
because they were
repackaged in a facility
with penicillin products
without adequate
separation which could
introduce the potential
for cross contamination
with penicillin.
Penicillin Cross
Contamination: All lots of
Recalling firm
Attix
Pharmaceutic
als
Attix
Pharmaceutic
als
Attix
Pharmaceutic
166
Product
Type
Product
Description
pharmaceutical
ingredient
packaged in
varying grams or
kg in bags or
drums
Code info.
Class
Drugs
Theophylline
Anhydrous active
pharmaceutical
ingredient
packaged in
varying grams or
kg in bags or
drums
All lots
Class II
repackaged
and distributed
between
01/05/12 to
02/12/15
Drugs
Thimerosal active
pharmaceutical
ingredient
packaged in
varying grams or
kg in bags or
drums
All lots
Class II
repackaged
and distributed
between
01/05/12 to
02/12/15
Drugs
Thiotepa active
All lots
and distributed
between
01/05/12 to
02/12/15
Class II
Copyright© PerformRx, LLC 2015 All Rights Reserved
Reason for Recall
Recalling firm
all products repackaged
and distributed between
01/05/12 and 02/12/15
are being recalled
because they were
repackaged in a facility
with penicillin products
without adequate
separation which could
introduce the potential
for cross contamination
with penicillin.
Penicillin Cross
Contamination: All lots of
all products repackaged
and distributed between
01/05/12 and 02/12/15
are being recalled
because they were
repackaged in a facility
with penicillin products
without adequate
separation which could
introduce the potential
for cross contamination
with penicillin.
Penicillin Cross
Contamination: All lots of
all products repackaged
and distributed between
01/05/12 and 02/12/15
are being recalled
because they were
repackaged in a facility
with penicillin products
without adequate
separation which could
introduce the potential
for cross contamination
with penicillin.
Penicillin Cross
als
Attix
Pharmaceutic
als
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Pharmaceutic
als
Attix
167
Product
Type
Product
Description
pharmaceutical
ingredient
packaged in
varying grams or
kg in bags or
drums
Code info.
Drugs
Thyroid Porcine
active
pharmaceutical
ingredient
packaged in
varying grams or
kg in bags or
drums
All lots
Class II
repackaged
and distributed
between
01/05/12 to
02/12/15
Drugs
Ticarcillin
Sodium/Potassiu
m Clavulanate
(30:1) active
pharmaceutical
ingredient
packaged in
varying grams or
kg in bags or
drums
Tiopronin Base
active
pharmaceutical
ingredient
All lots
Class II
repackaged
and distributed
between
01/05/12 to
02/12/15
Drugs
Class
repackaged
and distributed
between
01/05/12 to
02/12/15
All lots
Class II
repackaged
and distributed
between
Copyright© PerformRx, LLC 2015 All Rights Reserved
Reason for Recall
Recalling firm
Contamination: All lots of
all products repackaged
and distributed between
01/05/12 and 02/12/15
are being recalled
because they were
repackaged in a facility
with penicillin products
without adequate
separation which could
introduce the potential
for cross contamination
with penicillin.
Penicillin Cross
Contamination: All lots of
all products repackaged
and distributed between
01/05/12 and 02/12/15
are being recalled
because they were
repackaged in a facility
with penicillin products
without adequate
separation which could
introduce the potential
for cross contamination
with penicillin.
Stability Data Does Not
Support Expiry: All lots of
all products repackaged
and distributed between
01/05/12 and 02/12/15
are being recalled
because they were
repackaged without data
to support the printed
expiry date.
Penicillin Cross
Contamination: All lots of
all products repackaged
and distributed between
Pharmaceutic
als
Attix
Pharmaceutic
als
Attix
Pharmaceutic
als
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Pharmaceutic
als
168
Product
Type
Product
Description
packaged in
varying grams or
kg in bags or
drums
Code info.
Class
Drugs
Tizanidine HCl
active
pharmaceutical
ingredient
packaged in
varying grams or
kg in bags or
drums
All lots
Class II
repackaged
and distributed
between
01/05/12 to
02/12/15
Drugs
Tobramycin Base
active
pharmaceutical
ingredient
packaged in
varying grams or
kg in bags or
drums
All lots
Class II
repackaged
and distributed
between
01/05/12 to
02/12/15
Drugs
Tobramycin
Sulfate active
pharmaceutical
All lots
Class II
repackaged
and distributed
01/05/12 to
02/12/15
Copyright© PerformRx, LLC 2015 All Rights Reserved
Reason for Recall
01/05/12 and 02/12/15
are being recalled
because they were
repackaged in a facility
with penicillin products
without adequate
separation which could
introduce the potential
for cross contamination
with penicillin.
Penicillin Cross
Contamination: All lots of
all products repackaged
and distributed between
01/05/12 and 02/12/15
are being recalled
because they were
repackaged in a facility
with penicillin products
without adequate
separation which could
introduce the potential
for cross contamination
with penicillin.
Penicillin Cross
Contamination: All lots of
all products repackaged
and distributed between
01/05/12 and 02/12/15
are being recalled
because they were
repackaged in a facility
with penicillin products
without adequate
separation which could
introduce the potential
for cross contamination
with penicillin.
Penicillin Cross
Contamination: All lots of
all products repackaged
Recalling firm
Attix
Pharmaceutic
als
Attix
Pharmaceutic
als
Attix
Pharmaceutic
als
169
Product
Type
Product
Description
ingredient
packaged in
varying grams or
kg in bags or
drums
Code info.
Class
Drugs
Tolfenamic Acid
active
pharmaceutical
ingredient
packaged in
varying grams or
kg in bags or
drums
All lots
Class II
repackaged
and distributed
between
01/05/12 to
02/12/15
Drugs
Tolvaptan active
pharmaceutical
ingredient
packaged in
varying grams or
kg in bags or
drums
All lots
Class II
repackaged
and distributed
between
01/05/12 to
02/12/15
Drugs
Topiramate active All lots
pharmaceutical
repackaged
between
01/05/12 to
02/12/15
Class II
Copyright© PerformRx, LLC 2015 All Rights Reserved
Reason for Recall
and distributed between
01/05/12 and 02/12/15
are being recalled
because they were
repackaged in a facility
with penicillin products
without adequate
separation which could
introduce the potential
for cross contamination
with penicillin.
Penicillin Cross
Contamination: All lots of
all products repackaged
and distributed between
01/05/12 and 02/12/15
are being recalled
because they were
repackaged in a facility
with penicillin products
without adequate
separation which could
introduce the potential
for cross contamination
with penicillin.
Penicillin Cross
Contamination: All lots of
all products repackaged
and distributed between
01/05/12 and 02/12/15
are being recalled
because they were
repackaged in a facility
with penicillin products
without adequate
separation which could
introduce the potential
for cross contamination
with penicillin.
Penicillin Cross
Contamination: All lots of
Recalling firm
Attix
Pharmaceutic
als
Attix
Pharmaceutic
als
Attix
Pharmaceutic
170
Product
Type
Product
Description
ingredient
packaged in
varying grams or
kg in bags or
drums
Code info.
Class
Drugs
Tramadol HCl
active
pharmaceutical
ingredient
packaged in
varying grams or
kg in bags or
drums
All lots
Class II
repackaged
and distributed
between
01/05/12 to
02/12/15
Drugs
Tranexamic Acid
active
pharmaceutical
ingredient
packaged in
varying grams or
kg in bags or
drums
All lots
Class II
repackaged
and distributed
between
01/05/12 to
02/12/15
Drugs
Tranilast active
All lots
and distributed
between
01/05/12 to
02/12/15
Class II
Copyright© PerformRx, LLC 2015 All Rights Reserved
Reason for Recall
Recalling firm
all products repackaged
and distributed between
01/05/12 and 02/12/15
are being recalled
because they were
repackaged in a facility
with penicillin products
without adequate
separation which could
introduce the potential
for cross contamination
with penicillin.
Penicillin Cross
Contamination: All lots of
all products repackaged
and distributed between
01/05/12 and 02/12/15
are being recalled
because they were
repackaged in a facility
with penicillin products
without adequate
separation which could
introduce the potential
for cross contamination
with penicillin.
Penicillin Cross
Contamination: All lots of
all products repackaged
and distributed between
01/05/12 and 02/12/15
are being recalled
because they were
repackaged in a facility
with penicillin products
without adequate
separation which could
introduce the potential
for cross contamination
with penicillin.
Penicillin Cross
als
Attix
Pharmaceutic
als
Attix
Pharmaceutic
als
Attix
171
Product
Type
Product
Description
pharmaceutical
ingredient
packaged in
varying grams or
kg in bags or
drums
Code info.
Class
Drugs
Trazodone HCl
active
pharmaceutical
ingredient
packaged in
varying grams or
kg in bags or
drums
All lots
Class II
repackaged
and distributed
between
01/05/12 to
02/12/15
Drugs
Trehalose
Dihydrate active
pharmaceutical
ingredient
packaged in
varying grams or
kg in bags or
drums
All lots
Class II
repackaged
and distributed
between
01/05/12 to
02/12/15
repackaged
and distributed
between
01/05/12 to
02/12/15
Copyright© PerformRx, LLC 2015 All Rights Reserved
Reason for Recall
Recalling firm
Contamination: All lots of
all products repackaged
and distributed between
01/05/12 and 02/12/15
are being recalled
because they were
repackaged in a facility
with penicillin products
without adequate
separation which could
introduce the potential
for cross contamination
with penicillin.
Penicillin Cross
Contamination: All lots of
all products repackaged
and distributed between
01/05/12 and 02/12/15
are being recalled
because they were
repackaged in a facility
with penicillin products
without adequate
separation which could
introduce the potential
for cross contamination
with penicillin.
Penicillin Cross
Contamination: All lots of
all products repackaged
and distributed between
01/05/12 and 02/12/15
are being recalled
because they were
repackaged in a facility
with penicillin products
without adequate
separation which could
introduce the potential
for cross contamination
with penicillin.
Pharmaceutic
als
Attix
Pharmaceutic
als
Attix
Pharmaceutic
als
172
Product
Type
Drugs
Product
Description
Tretinoin or AllTrans Retinoic
Acid active
pharmaceutical
ingredient
packaged in
varying grams or
kg in bags or
drums
Code info.
Class
Drugs
Trichlormethiazid
e active
pharmaceutical
ingredient
packaged in
varying grams or
kg in bags or
drums
All lots
Class II
repackaged
and distributed
between
01/05/12 to
02/12/15
Drugs
Trifluridine active
pharmaceutical
ingredient
packaged in
varying grams or
kg in bags or
drums
All lots
Class II
repackaged
and distributed
between
01/05/12 to
02/12/15
All lots
Class II
repackaged
and distributed
between
01/05/12 to
02/12/15
Copyright© PerformRx, LLC 2015 All Rights Reserved
Reason for Recall
Recalling firm
Penicillin Cross
Contamination: All lots of
all products repackaged
and distributed between
01/05/12 and 02/12/15
are being recalled
because they were
repackaged in a facility
with penicillin products
without adequate
separation which could
introduce the potential
for cross contamination
with penicillin.
Penicillin Cross
Contamination: All lots of
all products repackaged
and distributed between
01/05/12 and 02/12/15
are being recalled
because they were
repackaged in a facility
with penicillin products
without adequate
separation which could
introduce the potential
for cross contamination
with penicillin.
Penicillin Cross
Contamination: All lots of
all products repackaged
and distributed between
01/05/12 and 02/12/15
are being recalled
because they were
repackaged in a facility
with penicillin products
without adequate
separation which could
introduce the potential
for cross contamination
Attix
Pharmaceutic
als
Attix
Pharmaceutic
als
Attix
Pharmaceutic
als
173
Product
Type
Product
Description
Code info.
Class
Drugs
Trimeprazine
Tartrate active
pharmaceutical
ingredient
packaged in
varying grams or
kg in bags or
drums
All lots
Class II
repackaged
and distributed
between
01/05/12 to
02/12/15
Drugs
Uridine5'Triphosphate
Trisodium Salt
active
pharmaceutical
ingredient
packaged in
varying grams or
kg in bags or
drums
All lots
Class II
repackaged
and distributed
between
01/05/12 to
02/12/15
Drugs
Ursodiol active
pharmaceutical
ingredient
packaged in
varying grams or
kg in bags or
drums
All lots
Class II
repackaged
and distributed
between
01/05/12 to
02/12/15
Copyright© PerformRx, LLC 2015 All Rights Reserved
Reason for Recall
with penicillin.
Penicillin Cross
Contamination: All lots of
all products repackaged
and distributed between
01/05/12 and 02/12/15
are being recalled
because they were
repackaged in a facility
with penicillin products
without adequate
separation which could
introduce the potential
for cross contamination
with penicillin.
Penicillin Cross
Contamination: All lots of
all products repackaged
and distributed between
01/05/12 and 02/12/15
are being recalled
because they were
repackaged in a facility
with penicillin products
without adequate
separation which could
introduce the potential
for cross contamination
with penicillin.
Penicillin Cross
Contamination: All lots of
all products repackaged
and distributed between
01/05/12 and 02/12/15
are being recalled
because they were
repackaged in a facility
with penicillin products
without adequate
separation which could
introduce the potential
Recalling firm
Attix
Pharmaceutic
als
Attix
Pharmaceutic
als
Attix
Pharmaceutic
als
174
Product
Type
Product
Description
Code info.
Class
Drugs
Valacyclovir HCl
active
pharmaceutical
ingredient
packaged in
varying grams or
kg in bags or
drums
All lots
Class II
repackaged
and distributed
between
01/05/12 to
02/12/15
Drugs
Vancomycin HCl
active
pharmaceutical
ingredient
packaged in
varying grams or
kg in bags or
drums
All lots
Class II
repackaged
and distributed
between
01/05/12 to
02/12/15
Drugs
Vardenafil HCl
Trihydrate active
pharmaceutical
ingredient
packaged in
varying grams or
kg in bags or
drums
All lots
Class II
repackaged
and distributed
between
01/05/12 to
02/12/15
Copyright© PerformRx, LLC 2015 All Rights Reserved
Reason for Recall
for cross contamination
with penicillin.
Penicillin Cross
Contamination: All lots of
all products repackaged
and distributed between
01/05/12 and 02/12/15
are being recalled
because they were
repackaged in a facility
with penicillin products
without adequate
separation which could
introduce the potential
for cross contamination
with penicillin.
Penicillin Cross
Contamination: All lots of
all products repackaged
and distributed between
01/05/12 and 02/12/15
are being recalled
because they were
repackaged in a facility
with penicillin products
without adequate
separation which could
introduce the potential
for cross contamination
with penicillin.
Penicillin Cross
Contamination: All lots of
all products repackaged
and distributed between
01/05/12 and 02/12/15
are being recalled
because they were
repackaged in a facility
with penicillin products
without adequate
separation which could
Recalling firm
Attix
Pharmaceutic
als
Attix
Pharmaceutic
als
Attix
Pharmaceutic
als
175
Product
Type
Product
Description
Code info.
Class
Drugs
Vecuronium
Bromide active
pharmaceutical
ingredient
packaged in
varying grams or
kg in bags or
drums
All lots
Class II
repackaged
and distributed
between
01/05/12 to
02/12/15
Drugs
Venlafaxine HCl
active
pharmaceutical
ingredient
packaged in
varying grams or
kg in bags or
drums
All lots
Class II
repackaged
and distributed
between
01/05/12 to
02/12/15
Drugs
Vidarbine
Monophosphate
active
pharmaceutical
ingredient
packaged in
varying grams or
kg in bags or
drums
All lots
Class II
repackaged
and distributed
between
01/05/12 to
02/12/15
Copyright© PerformRx, LLC 2015 All Rights Reserved
Reason for Recall
introduce the potential
for cross contamination
with penicillin.
Penicillin Cross
Contamination: All lots of
all products repackaged
and distributed between
01/05/12 and 02/12/15
are being recalled
because they were
repackaged in a facility
with penicillin products
without adequate
separation which could
introduce the potential
for cross contamination
with penicillin.
Penicillin Cross
Contamination: All lots of
all products repackaged
and distributed between
01/05/12 and 02/12/15
are being recalled
because they were
repackaged in a facility
with penicillin products
without adequate
separation which could
introduce the potential
for cross contamination
with penicillin.
Penicillin Cross
Contamination: All lots of
all products repackaged
and distributed between
01/05/12 and 02/12/15
are being recalled
because they were
repackaged in a facility
with penicillin products
without adequate
Recalling firm
Attix
Pharmaceutic
als
Attix
Pharmaceutic
als
Attix
Pharmaceutic
als
176
Product
Type
Product
Description
Code info.
Class
Drugs
Vincristine
Sulfate active
pharmaceutical
ingredient
packaged in
varying grams or
kg in bags or
drums
All lots
Class II
repackaged
and distributed
between
01/05/12 to
02/12/15
Drugs
Voriconazole
active
pharmaceutical
ingredient
packaged in
varying grams or
kg in bags or
drums
All lots
Class II
repackaged
and distributed
between
01/05/12 to
02/12/15
Drugs
Zidovudine active
pharmaceutical
ingredient
packaged in
varying grams or
kg in bags or
drums
All lots
Class II
repackaged
and distributed
between
01/05/12 to
02/12/15
Copyright© PerformRx, LLC 2015 All Rights Reserved
Reason for Recall
separation which could
introduce the potential
for cross contamination
with penicillin.
Penicillin Cross
Contamination: All lots of
all products repackaged
and distributed between
01/05/12 and 02/12/15
are being recalled
because they were
repackaged in a facility
with penicillin products
without adequate
separation which could
introduce the potential
for cross contamination
with penicillin.
Penicillin Cross
Contamination: All lots of
all products repackaged
and distributed between
01/05/12 and 02/12/15
are being recalled
because they were
repackaged in a facility
with penicillin products
without adequate
separation which could
introduce the potential
for cross contamination
with penicillin.
Penicillin Cross
Contamination: All lots of
all products repackaged
and distributed between
01/05/12 and 02/12/15
are being recalled
because they were
repackaged in a facility
with penicillin products
Recalling firm
Attix
Pharmaceutic
als
Attix
Pharmaceutic
als
Attix
Pharmaceutic
als
177
Product
Type
Product
Description
Code info.
Class
Drugs
Zinc Pyrithione
active
pharmaceutical
ingredient
packaged in
varying grams or
kg in bags or
drums
All lots
Class II
repackaged
and distributed
between
01/05/12 to
02/12/15
Drugs
Zoledronic Acid
active
pharmaceutical
ingredient
packaged in
varying grams or
kg in bags or
drums
All lots
Class II
repackaged
and distributed
between
01/05/12 to
02/12/15
Drugs
Zolmitriptan
active
pharmaceutical
ingredient
packaged in
varying grams or
kg in bags or
drums
All lots
Class II
repackaged
and distributed
between
01/05/12 to
02/12/15
Copyright© PerformRx, LLC 2015 All Rights Reserved
Reason for Recall
without adequate
separation which could
introduce the potential
for cross contamination
with penicillin.
Penicillin Cross
Contamination: All lots of
all products repackaged
and distributed between
01/05/12 and 02/12/15
are being recalled
because they were
repackaged in a facility
with penicillin products
without adequate
separation which could
introduce the potential
for cross contamination
with penicillin.
Penicillin Cross
Contamination: All lots of
all products repackaged
and distributed between
01/05/12 and 02/12/15
are being recalled
because they were
repackaged in a facility
with penicillin products
without adequate
separation which could
introduce the potential
for cross contamination
with penicillin.
Penicillin Cross
Contamination: All lots of
all products repackaged
and distributed between
01/05/12 and 02/12/15
are being recalled
because they were
repackaged in a facility
Recalling firm
Attix
Pharmaceutic
als
Attix
Pharmaceutic
als
Attix
Pharmaceutic
als
178
Product
Type
Product
Description
Code info.
Class
Reason for Recall
with penicillin products
without adequate
separation which could
introduce the potential
for cross contamination
with penicillin.
Penicillin Cross
Contamination: All lots of
all products repackaged
and distributed between
01/05/12 and 02/12/15
are being recalled
because they were
repackaged in a facility
with penicillin products
without adequate
separation which could
introduce the potential
for cross contamination
with penicillin.
Presence of particulate.
Recalling firm
Drugs
Zonisamide active
pharmaceutical
ingredient
packaged in
varying grams or
kg in bags or
drums
All lots
Class II
repackaged
and distributed
between
01/05/12 to
02/12/15
Drugs
Droperidol
injection, 2.5
mg/mL, 5 mg
Total Dose, 2 mL
Fill Volume per
syringe, packaged
in 10-count
syringes per heat
sealed bag, RX
only
0.9% Sodium
Chloride
Injection, USP,
100 mL ADDVantage Unit, Rx
only
Comfort Gel
Alumina/Magnesi
a/Simethicone/A
ntacid & Anti-Gas
(aluminum
Lot:
20141223@20
Class II
Lot# 44-110JT; Exp 08/16
Class II
Lack of Sterility
Assurance: The product
has the potential to leak
at the administrative
port.
Hospira Inc.
Lot #: 7579
(Refer to
13G0001),
7580 (Refer to
13G0003), Exp
Class II
Does Not Meet
Monograph: Products
failed the Antimicrobial
Effectiveness Test per
USP <51> for
Tarmac
Products, Inc.
Drugs
Drugs
Copyright© PerformRx, LLC 2015 All Rights Reserved
Attix
Pharmaceutic
als
SCA
Pharmaceutic
als
179
Product
Type
Drugs
Drugs
Product
Description
hydroxide 400
mg, magnesium
hydroxide 400
mg, simethicone
40 mg in each 5
mL, 1 teaspoon)
Maximum
Strength liquid,
12 FL OZ (355 mL)
bottle
Comfort Gel
Alumina/Magnesi
a/Simethicone/A
ntacid & Anti-Gas
(aluminum
hydroxide 200
mg, magnesium
hydroxide 200
mg, simethicone
20 mg in each 5
mL, 1 teaspoon)
Regular Strength
liquid, Cherry
Flavor, 12 FL OZ
(355 mL)
Antacid Liquid
Alumina/Magnesi
a/Simethicone/A
ntacid & Anti-Gas
(aluminum
hydroxide 200
mg, magnesium
hydroxide 200
mg, simethicone
20 mg in each 5
mL, 1 teaspoon)
Regular Strength
Liquid, Mint
Flavor,12 FL OZ
(355 mL)bottle
Code info.
Class
06/15
Lot #: 7568
(Refer to
13F0007), Exp
04/15; 7569
(Refer to
13F0008), Exp
05/15; 7618
(Refer to
13G0013),
7619 (Refer to
13F0013), Exp
07/15; 7620
(Refer to
13I0001), Exp
08/15 NDC
0363-0050-01.
Lot #: 7730
(Refer to
14B0001), Exp
10/15
Reason for Recall
Recalling firm
preservative
effectiveness.
Class II
Does Not Meet
Monograph: Products
failed the Antimicrobial
Effectiveness Test per
USP <51> for
preservative
effectiveness.
Tarmac
Products, Inc.
Class II
Does Not Meet
Monograph: Products
failed the Antimicrobial
Effectiveness Test per
USP <51> for
preservative
effectiveness.
Tarmac
Products, Inc
Copyright© PerformRx, LLC 2015 All Rights Reserved
180
Product
Type
Drugs
Product
Description
Fluoxetine
Capsules USP, 10
mg, in 100-count
bottles, Rx only
Code info.
Class
Reason for Recall
Recalling firm
Lot #:
6A207012, Exp
7/2015.
Class II
Teva
Pharmaceutic
als USA
Drugs
Fluoxetine
Capsules USP, 20
mg, packaged in
a) 500-count
bottles, and (b)
1000- count
bottles, Rx only
Lot #: a)
6A208123, Exp
8/2015; b)
6A208121, Exp
8/2015.
Class II
Drugs
Ketorolac
Tromethamine
Inj. USP, 30 mg
(30 mg/mL), 1 mL
Fill, Single-dose
vial, Rx Only
Lots 35-231Class II
DK, 35-235-DK,
35-507-DK Exp.
Date
1NOV2015; Lot
36-136-DK Exp.
Date
1DEC2015; Lot
37-146-DK Exp.
Date
1JAN2016; Lot
38-138-DK Exp.
Date
1FEB2016; Lots
39-103-DK, 39255-DK Exp.
Date
1MAR2016;
Lots 40-539DK, 40-549-DK,
Exp. Date
1APR2016; Lot
41-079-DK Exp.
Chemical Contamination:
Product recalled due to
an elevated level of a
residual solvent impurity
in the API that exceeds
the Threshold of
Toxicological Concern
(TTC) calculation for the
impurity.
Chemical Contamination:
Product recalled due to
an elevated level of a
residual solvent impurity
in the API that exceeds
the Threshold of
Toxicological Concern
(TTC) calculation for the
impurity.
Crystallization
Copyright© PerformRx, LLC 2015 All Rights Reserved
Teva
Pharmaceutic
als USA
Hospira Inc.
181
Product
Type
Product
Description
Drugs
Ketorolac
Tromethamine
Inj. USP, 60 mg
(30 mg/mL), 2 mL
Fill, Single-dose
vial, Rx Only,
Drugs
Captopril Tablets,
USP 12.5 mg, Rx
Only, a) 100
count bottles, b)
1000 count
bottles
Code info.
Class
Date
1MAY2016;
Lots 42-252DK, 42-254-DK
Exp. Date
1JUN2016;
Lots 43-262DK, 43-263-DK
Exp. Date ...
More
Lot 38-135-DK, Class II
38-136-DK Exp.
Date
1FEB2016; Lots
44-075-DK, 44356-DK Exp.
Date
1AUG2016;
Lots 44-357DK, 44-358-DK
Exp. Date
1AUG2016; Lot
46-308-DK Exp.
Date
1OCT2016 Note: The lot
number may
be followed
by ...
More
Lot #s: a)
Class II
LM10525, Exp
03/15;
LM10727, Exp
04/15;
LM11519, Exp
08/15;
LN10008, Exp
11/15;
LN10121, Exp
12/15;
Copyright© PerformRx, LLC 2015 All Rights Reserved
Reason for Recall
Recalling firm
Crystallization
Hospira Inc.
Failed Tablet/Capsule
Specifications: out of
specification for
thickness.
Wockhardt
Usa Inc.
182
Product
Type
Product
Description
Drugs
Alinia
(nitazoxanide),
powder for oral
suspension,
100mg/5mL, 60
mL/bottle. Rx
only
Drugs
C-Topical 4% CII
(cocaine
hydrochloride),
topical solution, 4
ml bottle, Rx Only
KETOROLAC
TROM 30 MG/ML
INJ, 1 mL glass
vials repackaged
individually inside
an amber glass
bottle
Drugs
Code info.
LN10887, Exp
04/16;
LM11248, Exp
06/16 Lot #s:
b) LM10522,
Exp 03/15;
LM10726, Exp
04/15;
LN10007, Exp
11/15;
LN10116, Exp
12/15;
LN10888, Exp
04/16;
LN11281 Exp
07/16
Lot #:
MTEW1721,
MTCW21281,
MTCW21291,
Exp 09/2016;
Lot #:
MTEW5791,
Exp 12/2016;
Lot #:
MTEW5801,
Exp 01/2017.
Lot 14834012,
Exp 01/2016
Lot #
B0069266013015, Lot #
B0069264013015, Lot #
B0066712011415, EXP
DATE
9/01/2016
Class
Reason for Recall
Class II
Failed Stability
Romark
Specifications: Product
Laboratories,
failed to meet 12 months L.C.
long term stability
specification for viscosity
Class II
Labeling: Label mix-up;
bottles were incorrectly
labeled as 10 mL instead
of correctly labeled as 4
mL
Crystallization
Class II
Copyright© PerformRx, LLC 2015 All Rights Reserved
Recalling firm
Cody
Laboratories,
Inc.
RemedyRepac
k Inc.
183
Product
Type
Drugs
Product
Code info.
Description
17-HP
All lots
Hydroxyprogester
one 250mg/1ml
Injection
Class
Reason for Recall
Recalling firm
Class II
Health
Innovations
Pharmacy, Inc
Drugs
HCG 1000
Units/mL
Injection
All lots
Class II
Drugs
Cyanocobalamin
2000mcg/1ml
Injection
All lots
Class II
Drugs
Methylcobalamin
1000 mcg/mL
Injection
All lots
Class II
Drugs
Sodium
All lots
Class II
Lack of Assurance of
Sterility and Stability
Data does not Support
Expiry: recent inspection
due to observations
associated with certain
quality control
procedures that present
a risk to sterility and
quality assurance.
Lack of Assurance of
Sterility and Stability
Data does not Support
Expiry: recent inspection
due to observations
associated with certain
quality control
procedures that present
a risk to sterility and
quality assurance.
Lack of Assurance of
Sterility and Stability
Data does not Support
Expiry: recent inspection
due to observations
associated with certain
quality control
procedures that present
a risk to sterility and
quality assurance.
Lack of Assurance of
Sterility and Stability
Data does not Support
Expiry: recent inspection
due to observations
associated with certain
quality control
procedures that present
a risk to sterility and
quality assurance.
Lack of Assurance of
Copyright© PerformRx, LLC 2015 All Rights Reserved
Health
Innovations
Pharmacy, Inc
Health
Innovations
Pharmacy, Inc
Health
Innovations
Pharmacy, Inc
Health
184
Product
Type
Product
Description
Tetradecyl 1%
Injection
Code info.
Laureth-P 1%
Injection
(Polidocanol)
All lots
Class II
Drugs
Trimix #1
(Original)
Injection
(papaverine 75
mg phentolamine 2.5
mg - PGE 25
mcg/10 mL)
All lots
Class II
Drugs
Dexamethasone 4 All lots
mg/mL
Iontophoresis
Class II
Drugs
Fortifed
Tobramycin 15
Class II
All lots
Class
Copyright© PerformRx, LLC 2015 All Rights Reserved
Reason for Recall
Recalling firm
Sterility and Stability
Data does not Support
Expiry: recent inspection
due to observations
associated with certain
quality control
procedures that present
a risk to sterility and
quality assurance.
Lack of Assurance of
Sterility and Stability
Data does not Support
Expiry: recent inspection
due to observations
associated with certain
quality control
procedures that present
a risk to sterility and
quality assurance.
Lack of Assurance of
Sterility and Stability
Data does not Support
Expiry: recent inspection
due to observations
associated with certain
quality control
procedures that present
a risk to sterility and
quality assurance.
Lack of Assurance of
Sterility and Stability
Data does not Support
Expiry: recent inspection
due to observations
associated with certain
quality control
procedures that present
a risk to sterility and
quality assurance.
Lack of Assurance of
Sterility and Stability
Innovations
Pharmacy, Inc
Health
Innovations
Pharmacy, Inc
Health
Innovations
Pharmacy, Inc
Health
Innovations
Pharmacy, Inc
Health
Innovations
185
Product
Type
Product
Description
mg/1 mL Opth
Code info.
Class
Drugs
Glycerin 98.5%
Opth. Solution
All lots
Class II
Drugs
EDTA 3% Eye
Drops
All lots
Class II
Drugs
Serum 50% BSS
50% Opth Drops
All lots
Class II
Drugs
Phospholine
Iodide 0.03%
Opth Drops
All lots
Class II
Copyright© PerformRx, LLC 2015 All Rights Reserved
Reason for Recall
Recalling firm
Data does not Support
Expiry: recent inspection
due to observations
associated with certain
quality control
procedures that present
a risk to sterility and
quality assurance.
Lack of Assurance of
Sterility and Stability
Data does not Support
Expiry: recent inspection
due to observations
associated with certain
quality control
procedures that present
a risk to sterility and
quality assurance.
Lack of Assurance of
Sterility and Stability
Data does not Support
Expiry: recent inspection
due to observations
associated with certain
quality control
procedures that present
a risk to sterility and
quality assurance.
Lack of Assurance of
Sterility and Stability
Data does not Support
Expiry: recent inspection
due to observations
associated with certain
quality control
procedures that present
a risk to sterility and
quality assurance.
Lack of Assurance of
Sterility and Stability
Data does not Support
Pharmacy, Inc
Health
Innovations
Pharmacy, Inc
Health
Innovations
Pharmacy, Inc
Health
Innovations
Pharmacy, Inc
Health
Innovations
Pharmacy, Inc
186
Product
Type
Product
Description
Code info.
Class
Drugs
Progest 200 mg/1
mL Cream
All lots
Class II
Drugs
Testosterone 100
mg/1 mL
Injection
All lots
Class II
Drugs
Estradiol 0.01%
Vaginal Cream
All lots
Class II
Drugs
Estriol 5% Cream
Vaginal Cream
All lots
Class II
Copyright© PerformRx, LLC 2015 All Rights Reserved
Reason for Recall
Expiry: recent inspection
due to observations
associated with certain
quality control
procedures that present
a risk to sterility and
quality assurance.
Lack of Assurance of
Sterility and Stability
Data does not Support
Expiry: recent inspection
due to observations
associated with certain
quality control
procedures that present
a risk to sterility and
quality assurance.
Lack of Assurance of
Sterility and Stability
Data does not Support
Expiry: recent inspection
due to observations
associated with certain
quality control
procedures that present
a risk to sterility and
quality assurance.
Lack of Assurance of
Sterility and Stability
Data does not Support
Expiry: recent inspection
due to observations
associated with certain
quality control
procedures that present
a risk to sterility and
quality assurance.
Lack of Assurance of
Sterility and Stability
Data does not Support
Expiry: recent inspection
Recalling firm
Health
Innovations
Pharmacy, Inc
Health
Innovations
Pharmacy, Inc
Health
Innovations
Pharmacy, Inc
Health
Innovations
Pharmacy, Inc
187
Product
Type
Product
Description
Code info.
Class
Drugs
Naltrexone 4.5
mg Caps
All lots
Class II
Drugs
Ibuprofen 10%
cream
All lots
Class II
Drugs
Acetylcysteine
10% Opth
Solution
All lots
Class II
Drugs
Voriconazole 1%
Opth Drops
All lots
Class II
Copyright© PerformRx, LLC 2015 All Rights Reserved
Reason for Recall
due to observations
associated with certain
quality control
procedures that present
a risk to sterility and
quality assurance.
Lack of Assurance of
Sterility and Stability
Data does not Support
Expiry: recent inspection
due to observations
associated with certain
quality control
procedures that present
a risk to sterility and
quality assurance.
Lack of Assurance of
Sterility and Stability
Data does not Support
Expiry: recent inspection
due to observations
associated with certain
quality control
procedures that present
a risk to sterility and
quality assurance.
Lack of Assurance of
Sterility and Stability
Data does not Support
Expiry: recent inspection
due to observations
associated with certain
quality control
procedures that present
a risk to sterility and
quality assurance.
Lack of Assurance of
Sterility and Stability
Data does not Support
Expiry: recent inspection
due to observations
Recalling firm
Health
Innovations
Pharmacy, Inc
Health
Innovations
Pharmacy, Inc
Health
Innovations
Pharmacy, Inc
Health
Innovations
Pharmacy, Inc
188
Product
Type
Product
Description
Code info.
Class
Drugs
DHEA 10 mg SR
Caps
All lots
Class II
Drugs
Pregnenolone 20
mg SR Capsule
All lots
Class II
Drugs
BLT New Formula
20%/7%/7%
Sample
All lots
Class II
Drugs
Keto 10%-Gabap
10%-Ketamine
2% Cream
All lots
Class II
Copyright© PerformRx, LLC 2015 All Rights Reserved
Reason for Recall
associated with certain
quality control
procedures that present
a risk to sterility and
quality assurance.
Lack of Assurance of
Sterility and Stability
Data does not Support
Expiry: recent inspection
due to observations
associated with certain
quality control
procedures that present
a risk to sterility and
quality assurance.
Lack of Assurance of
Sterility and Stability
Data does not Support
Expiry: recent inspection
due to observations
associated with certain
quality control
procedures that present
a risk to sterility and
quality assurance.
Lack of Assurance of
Sterility and Stability
Data does not Support
Expiry: recent inspection
due to observations
associated with certain
quality control
procedures that present
a risk to sterility and
quality assurance.
Lack of Assurance of
Sterility and Stability
Data does not Support
Expiry: recent inspection
due to observations
associated with certain
Recalling firm
Health
Innovations
Pharmacy, Inc
Health
Innovations
Pharmacy, Inc
Health
Innovations
Pharmacy, Inc
Health
Innovations
Pharmacy, Inc
189
Product
Type
Product
Description
Code info.
Class
Drugs
Boric Acid Vaginal All lots
Capsules
Class II
Drugs
Baclofen 20 mg/4
mL Susp.
All lots
Class II
Drugs
T4 66mcg - T3
All lots
10mcg SR Capsule
Class II
Drugs
Promethazine 25
mg/0.5 mLGel
Class II
All lots
Copyright© PerformRx, LLC 2015 All Rights Reserved
Reason for Recall
quality control
procedures that present
a risk to sterility and
quality assurance.
Lack of Assurance of
Sterility and Stability
Data does not Support
Expiry: recent inspection
due to observations
associated with certain
quality control
procedures that present
a risk to sterility and
quality assurance.
Lack of Assurance of
Sterility and Stability
Data does not Support
Expiry: recent inspection
due to observations
associated with certain
quality control
procedures that present
a risk to sterility and
quality assurance.
Lack of Assurance of
Sterility and Stability
Data does not Support
Expiry: recent inspection
due to observations
associated with certain
quality control
procedures that present
a risk to sterility and
quality assurance.
Lack of Assurance of
Sterility and Stability
Data does not Support
Expiry: recent inspection
due to observations
associated with certain
quality control
Recalling firm
Health
Innovations
Pharmacy, Inc
Health
Innovations
Pharmacy, Inc
Health
Innovations
Pharmacy, Inc
Health
Innovations
Pharmacy, Inc
190
Product
Type
Product
Description
Code info.
Class
Drugs
Leucovorin 1
mg/1 mL Susp
All lots
Class II
Drugs
Diclo 3% - Bacl
2% - Cyclo 2% Lidoc 2% Cream
All lots
Class II
Drugs
Warfarin 2.5 ng
All lots
Lactose Free Caps
Class II
Drugs
Nitroglycerin
0.2% Compd
Cream
Class II
All lots
Copyright© PerformRx, LLC 2015 All Rights Reserved
Reason for Recall
procedures that present
a risk to sterility and
quality assurance.
Lack of Assurance of
Sterility and Stability
Data does not Support
Expiry: recent inspection
due to observations
associated with certain
quality control
procedures that present
a risk to sterility and
quality assurance.
Lack of Assurance of
Sterility and Stability
Data does not Support
Expiry: recent inspection
due to observations
associated with certain
quality control
procedures that present
a risk to sterility and
quality assurance.
Lack of Assurance of
Sterility and Stability
Data does not Support
Expiry: recent inspection
due to observations
associated with certain
quality control
procedures that present
a risk to sterility and
quality assurance.
Lack of Assurance of
Sterility and Stability
Data does not Support
Expiry: recent inspection
due to observations
associated with certain
quality control
procedures that present
Recalling firm
Health
Innovations
Pharmacy, Inc
Health
Innovations
Pharmacy, Inc
Health
Innovations
Pharmacy, Inc
Health
Innovations
Pharmacy, Inc
191
Product
Type
Product
Description
Code info.
Class
Drugs
Spironolactone 5
mg/mL Susp
All lots
Class II
Drugs
Carvedilol 1.25
mg/mL
All lots
Class II
Drugs
Pyrimethamine 2
mg/1 mL Susp
All lots
Class II
Drugs
Nortriptyline 10
mg/5 mL Susp
All lots
Class II
Copyright© PerformRx, LLC 2015 All Rights Reserved
Reason for Recall
a risk to sterility and
quality assurance.
Lack of Assurance of
Sterility and Stability
Data does not Support
Expiry: recent inspection
due to observations
associated with certain
quality control
procedures that present
a risk to sterility and
quality assurance.
Lack of Assurance of
Sterility and Stability
Data does not Support
Expiry: recent inspection
due to observations
associated with certain
quality control
procedures that present
a risk to sterility and
quality assurance.
Lack of Assurance of
Sterility and Stability
Data does not Support
Expiry: recent inspection
due to observations
associated with certain
quality control
procedures that present
a risk to sterility and
quality assurance.
Lack of Assurance of
Sterility and Stability
Data does not Support
Expiry: recent inspection
due to observations
associated with certain
quality control
procedures that present
a risk to sterility and
Recalling firm
Health
Innovations
Pharmacy, Inc
Health
Innovations
Pharmacy, Inc
Health
Innovations
Pharmacy, Inc
Health
Innovations
Pharmacy, Inc
192
Product
Type
Product
Description
Code info.
Class
Drugs
Nadolol 10 mg/1
mL Susp
All lots
Class II
Drugs
Levodopa 250 mg
NSR Capsules
All lots
Class II
Drugs
Glycopyrrolate
0.2 mg/1 mL Susp
(Robinul)
All lots
Class II
Drugs
Rifampin 25 mg/1 All lots
mL Susp
Class II
Copyright© PerformRx, LLC 2015 All Rights Reserved
Reason for Recall
quality assurance.
Lack of Assurance of
Sterility and Stability
Data does not Support
Expiry: recent inspection
due to observations
associated with certain
quality control
procedures that present
a risk to sterility and
quality assurance.
Lack of Assurance of
Sterility and Stability
Data does not Support
Expiry: recent inspection
due to observations
associated with certain
quality control
procedures that present
a risk to sterility and
quality assurance.
Lack of Assurance of
Sterility and Stability
Data does not Support
Expiry: recent inspection
due to observations
associated with certain
quality control
procedures that present
a risk to sterility and
quality assurance.
Lack of Assurance of
Sterility and Stability
Data does not Support
Expiry: recent inspection
due to observations
associated with certain
quality control
procedures that present
a risk to sterility and
quality assurance.
Recalling firm
Health
Innovations
Pharmacy, Inc
Health
Innovations
Pharmacy, Inc
Health
Innovations
Pharmacy, Inc
Health
Innovations
Pharmacy, Inc
193
Product
Type
Drugs
Product
Description
Nexium 2 mg/1
mL Solution
Code info.
Class
Reason for Recall
Recalling firm
All lots
Class II
Health
Innovations
Pharmacy, Inc
Drugs
Azithromycin 100
mg Rectal
Suppository
All lots
Class II
Drugs
Hydroquinone
10% Cream
All lots
Class II
Drugs
Fortified
Vancomycin 25
mg/1 mL Opth
Drops
All lots
Class II
Drugs
Folic Acid 2 mg/1
All lots
Class II
Lack of Assurance of
Sterility and Stability
Data does not Support
Expiry: recent inspection
due to observations
associated with certain
quality control
procedures that present
a risk to sterility and
quality assurance.
Lack of Assurance of
Sterility and Stability
Data does not Support
Expiry: recent inspection
due to observations
associated with certain
quality control
procedures that present
a risk to sterility and
quality assurance.
Lack of Assurance of
Sterility and Stability
Data does not Support
Expiry: recent inspection
due to observations
associated with certain
quality control
procedures that present
a risk to sterility and
quality assurance.
Lack of Assurance of
Sterility and Stability
Data does not Support
Expiry: recent inspection
due to observations
associated with certain
quality control
procedures that present
a risk to sterility and
quality assurance.
Lack of Assurance of
Copyright© PerformRx, LLC 2015 All Rights Reserved
Health
Innovations
Pharmacy, Inc
Health
Innovations
Pharmacy, Inc
Health
Innovations
Pharmacy, Inc
Health
194
Product
Type
Product
Description
mL Susp
Code info.
Drugs
Pyridoxine 100
mg/1 mL Syrup
All lots
Class II
Drugs
Nifedipine 0.2% - All lots
Lidocaine 2% Jelly
Class II
Drugs
Renacidin
All lots
Irrigation Solution
Class II
Drugs
Hydroxyurea 100
mg/1 mL Susp
Class II
All lots
Class
Copyright© PerformRx, LLC 2015 All Rights Reserved
Reason for Recall
Recalling firm
Sterility and Stability
Data does not Support
Expiry: recent inspection
due to observations
associated with certain
quality control
procedures that present
a risk to sterility and
quality assurance.
Lack of Assurance of
Sterility and Stability
Data does not Support
Expiry: recent inspection
due to observations
associated with certain
quality control
procedures that present
a risk to sterility and
quality assurance.
Lack of Assurance of
Sterility and Stability
Data does not Support
Expiry: recent inspection
due to observations
associated with certain
quality control
procedures that present
a risk to sterility and
quality assurance.
Lack of Assurance of
Sterility and Stability
Data does not Support
Expiry: recent inspection
due to observations
associated with certain
quality control
procedures that present
a risk to sterility and
quality assurance.
Lack of Assurance of
Sterility and Stability
Innovations
Pharmacy, Inc
Health
Innovations
Pharmacy, Inc
Health
Innovations
Pharmacy, Inc
Health
Innovations
Pharmacy, Inc
Health
Innovations
195
Product
Type
Product
Description
Code info.
Class
Drugs
Phenylephrine
0.5% Solution
(Bottle)
All lots
Class II
Drugs
Verapamil HCl
15% Topical
Cream
All lots
Class II
Drugs
Sildenafil 10 mg/1 All lots
mL Susp
Class II
Drugs
Ciprodex with
Amphoteracin B
(ear drops)
Class II
All lots
Copyright© PerformRx, LLC 2015 All Rights Reserved
Reason for Recall
Recalling firm
Data does not Support
Expiry: recent inspection
due to observations
associated with certain
quality control
procedures that present
a risk to sterility and
quality assurance.
Lack of Assurance of
Sterility and Stability
Data does not Support
Expiry: recent inspection
due to observations
associated with certain
quality control
procedures that present
a risk to sterility and
quality assurance.
Lack of Assurance of
Sterility and Stability
Data does not Support
Expiry: recent inspection
due to observations
associated with certain
quality control
procedures that present
a risk to sterility and
quality assurance.
Lack of Assurance of
Sterility and Stability
Data does not Support
Expiry: recent inspection
due to observations
associated with certain
quality control
procedures that present
a risk to sterility and
quality assurance.
Lack of Assurance of
Sterility and Stability
Data does not Support
Pharmacy, Inc
Health
Innovations
Pharmacy, Inc
Health
Innovations
Pharmacy, Inc
Health
Innovations
Pharmacy, Inc
Health
Innovations
Pharmacy, Inc
196
Product
Type
Product
Description
Code info.
Class
Drugs
DNCB 0.3%
Ointment
All lots
Class II
Drugs
Methenamine/Ph
enyl Salicylate
Capsule
All lots
Class II
Drugs
Thymol 2%
Solution
All lots
Class II
Drugs
Lansoprazole 3
mg/mL Susp
All lots
Class II
Copyright© PerformRx, LLC 2015 All Rights Reserved
Reason for Recall
Expiry: recent inspection
due to observations
associated with certain
quality control
procedures that present
a risk to sterility and
quality assurance.
Lack of Assurance of
Sterility and Stability
Data does not Support
Expiry: recent inspection
due to observations
associated with certain
quality control
procedures that present
a risk to sterility and
quality assurance.
Lack of Assurance of
Sterility and Stability
Data does not Support
Expiry: recent inspection
due to observations
associated with certain
quality control
procedures that present
a risk to sterility and
quality assurance.
Lack of Assurance of
Sterility and Stability
Data does not Support
Expiry: recent inspection
due to observations
associated with certain
quality control
procedures that present
a risk to sterility and
quality assurance.
Lack of Assurance of
Sterility and Stability
Data does not Support
Expiry: recent inspection
Recalling firm
Health
Innovations
Pharmacy, Inc
Health
Innovations
Pharmacy, Inc
Health
Innovations
Pharmacy, Inc
Health
Innovations
Pharmacy, Inc
197
Product
Type
Product
Description
Code info.
Class
Drugs
Colchicine 0.6 mg
Caps
All lots
Class II
Drugs
Triest 5 mg Progest 150 mg
Capsule
All lots
Class II
Drugs
Cyclandelate 200
mg Caps
All lots
Class II
Drugs
Coconut Oil
Suppository
All lots
Class II
Copyright© PerformRx, LLC 2015 All Rights Reserved
Reason for Recall
due to observations
associated with certain
quality control
procedures that present
a risk to sterility and
quality assurance.
Lack of Assurance of
Sterility and Stability
Data does not Support
Expiry: recent inspection
due to observations
associated with certain
quality control
procedures that present
a risk to sterility and
quality assurance.
Lack of Assurance of
Sterility and Stability
Data does not Support
Expiry: recent inspection
due to observations
associated with certain
quality control
procedures that present
a risk to sterility and
quality assurance.
Lack of Assurance of
Sterility and Stability
Data does not Support
Expiry: recent inspection
due to observations
associated with certain
quality control
procedures that present
a risk to sterility and
quality assurance.
Lack of Assurance of
Sterility and Stability
Data does not Support
Expiry: recent inspection
due to observations
Recalling firm
Health
Innovations
Pharmacy, Inc
Health
Innovations
Pharmacy, Inc
Health
Innovations
Pharmacy, Inc
Health
Innovations
Pharmacy, Inc
198
Product
Type
Product
Description
Code info.
Class
Drugs
Nystatin 50,000
Units Suppository
All lots
Class II
Drugs
Hydrocortisone
1.6 mg/0.5 mL
Susp
All lots
Class II
Drugs
Phen 15 mg Topri 92 mg SR
Cap (Qsymia)
All lots
Class II
Drugs
SULFAMETHOXAZ
OLE AND
TRIMETHOPRIM
ORAL
SUSPENSION,
USP,200 mg/ 40
Lot # 623940,
Exp. 10/2015;
Lot # 624487,
Exp. 11/2015;
Lot # 624741,
Exp. 11/2015;
Class II
Copyright© PerformRx, LLC 2015 All Rights Reserved
Reason for Recall
associated with certain
quality control
procedures that present
a risk to sterility and
quality assurance.
Lack of Assurance of
Sterility and Stability
Data does not Support
Expiry: recent inspection
due to observations
associated with certain
quality control
procedures that present
a risk to sterility and
quality assurance.
Lack of Assurance of
Sterility and Stability
Data does not Support
Expiry: recent inspection
due to observations
associated with certain
quality control
procedures that present
a risk to sterility and
quality assurance.
Lack of Assurance of
Sterility and Stability
Data does not Support
Expiry: recent inspection
due to observations
associated with certain
quality control
procedures that present
a risk to sterility and
quality assurance.
Failed Dissolution
Specifications: Out of
specification for
dissolution of
sulfamethoxazole.
Recalling firm
Health
Innovations
Pharmacy, Inc
Health
Innovations
Pharmacy, Inc
Health
Innovations
Pharmacy, Inc
Akorn, Inc.
199
Product
Type
Drugs
Product
Description
mg per 5mL,
CHERRY FLAVOR,
16 fl oz (473 mL)
bottles, Rx only
SULFAMETHOXAZ
OLE AND
TRIMETHOPRIM
ORAL
SUSPENSION,
USP,200 mg/ 40
mg per 5mL,
GRAPE FLAVOR,
16 fl oz (473 mL)
bottles, Rx only
Code info.
Class
Reason for Recall
Recalling firm
Class II
Failed Dissolution
Specifications: Out of
specification for
dissolution of
sulfamethoxazole.
Akorn, Inc.
Lot # 625296,
Exp. 1/2016
Lot # 618358,
Exp.
11/15/2015;Lo
t # 618646,
Exp.
11/18/2015;Lo
t # 618649,
Exp.
11/19/2015;Lo
t # 618652,
Exp.
11/20/2015;Lo
t # 618746,
Exp.
11/26/2015;Lo
t # 618749,
Exp.
11/27/2015;Lo
t # 618934,
Exp.
12/5/2015;Lot
# 618940, Exp.
12/6/2015;Lot
# 618946, Exp.
12/8/2015;Lot
# 621496, Exp.
5/13/2016;Lot
# 621890, Exp.
6/24/2016;Lot
# 622779, Exp.
7/27/2016;Lot
# 623389, Exp.
8/31/2016;Lot
# 623829, Exp.
9/27/2016;Lot
# 623946, Exp.
10/2/2016;Lot
Copyright© PerformRx, LLC 2015 All Rights Reserved
200
Product
Type
Product
Description
Code info.
Class
Reason for Recall
Recalling firm
# 623952, Exp.
10/3/2016;Lot
# 623955, Exp.
10/3/2016;Lot
# 624147, Exp.
10/8/2016;Lot
# 624153, Exp.
10/9/2016;Lot
# 624159, Exp.
10/15/2016;Lo
t # 624162,
Exp.
10/17/2016;Lo
t # 624271,
Exp.
10/18/2016;Lo
t # 624274,
Exp.
10/18/2016;Lo
t # 624490,
Exp.
10/23/2016;Lo
t # 624493,
Exp.
10/23/2016;Lo
t # 624496,
Exp.
10/25/2016;Lo
t # 624499,
Exp.
10/25/2016;Lo
t # 624744,
Exp.
11/6/2016;Lot
# 624747, Exp.
11/6/2016;Lot
# 624750, Exp.
11/8/2016;Lot
# 624753, Exp.
11/8/2016;Lot
# 624836, Exp.
Copyright© PerformRx, LLC 2015 All Rights Reserved
201
Product
Type
Drugs
Product
Description
SULFAMETHOXAZ
OLE AND
TRIMETHOPRIM
ORAL
SUSPENSION, USP
800 mg/ 160 mg
per 5mL, GRAPE
FLAVOR, 20 mL
unit dose cup, Rx
only,
Code info.
11/14/2016;Lo
t # 624839,
Exp.
11/15/2016;Lo
t # 625120,
Exp.
12/4/2016;Lot
# 625123, Exp.
12/29/2016;Lo
t # 625126,
Exp.
12/30/2016;Lo
t # 625795,
Exp.
1/14/2017;Lot
# 625918, Exp.
1/22/2017;Lot
# 625921, Exp.
1/23/2017;Lot
# 625924, Exp.
1/23/2017;Lot
# 625927, Exp.
1/24/2017;Lot
# 626211, Exp.
2/6/2017;Lot #
626465, Exp.
3/25/2017; Lot
# 626735, Exp.
3/5/2017;Lot #
626743, Exp.
3/20/2017
Lot # 624271,
Exp. Date
10/2015
Class
Reason for Recall
Recalling firm
Class II
Failed Dissolution
Specifications: Out of
specification for
dissolution of
sulfamethoxazole.
Akorn, Inc.
Copyright© PerformRx, LLC 2015 All Rights Reserved
202
Product
Type
Drugs
Drugs
Drugs
Drugs
Drugs
Drugs
Product
Description
Methylcobalamin
/Hydroxocobalam
in Rx 3.125/3.125
mg/0.5 mL
Injection
Methylcobalamin
/B-Complex Rx
2.5/103 mg/mL
Injection
Prostaglandin Rx,
dispensed in 5 ml
vials: 1) 10
mcg/mL Injection,
2) 22.5 mcg/mL
Injection, 3) 45
mcg/mL Injection,
4) 60 mcg/mL
Injection, 5) 80
mcg/mL Injection
Code info.
Class
Reason for Recall
Recalling firm
Lot#:
Class II
01272015@38,
Exp 3/28/15
Lack of assurance of
sterility
Fallon
Wellness
Pharmacy,
L.L.C.
Lot#:
Class II
02112015@35,
Exp 4/12/15
Lack of assurance of
sterility
Lot#: a)
Class II
10272014@1,
Exp 4/27/15;
b)
11042014@60,
Exp 4/12/15; c)
11192014@43,
Exp 4/12/15;
d)
12042014@32,
Exp 4/12/15;
e)
12182014@46
; Exp 4/12/15;
f)
12232014@8,
12242014@16,
Exp 4/12/15;
g)
12312014@40,
Exp 4/12/15
Papaverine/phent Lot #: a) 1031- Class II
olamine/prostagl 2014@51; Exp
andin 30/4/0.04
3/18/15; b)
mg/mL Injection
12152014@24
; Exp 4/12/15
Papaverine/phent Lot#:
Class II
olamine/prostagl 12012014@65
andin 30/1/0.025 ; Exp 4/12/15
mg/mL Injection
Papaverine/phent Lot#:
Class II
olamine/prostagl 12172014@42
Lack of assurance of
sterility
Fallon
Wellness
Pharmacy,
L.L.C.
Fallon
Wellness
Pharmacy,
L.L.C.
Copyright© PerformRx, LLC 2015 All Rights Reserved
Lack of assurance of
sterility
Fallon
Wellness
Pharmacy,
L.L.C.
Lack of assurance of
sterility
Fallon
Wellness
Pharmacy,
L.L.C.
Fallon
Wellness
Lack of assurance of
sterility
203
Product
Type
Drugs
Drugs
Drugs
Drugs
Product
Description
andin
16/0.5/0.005
mg/mL Injection
Papaverine/phent
olamine/prostagl
andin
30/1/0.01mg/mL
Injection
Methylcobolamin
1) 6500
mcg/0.26mL, 2)
1000
mcg/0.08mL, 3)
5000mcg/mL, 4)
3000mcg/0.12mL,
5)
4000mcg/0.16mL,
6) 1000mcg/mL
and 7) 1000
mcg/0.04mL
injection
Hydroxocobalami
n 1)
1000mcg/mL, 2)
5mg/0.5mL, 3)
5000mcg/0.2mL
injection
CLASS III
Fluorescein
Sodium
Ophthalmic Strips
USP, 0.6 mg per
Code info.
Class
Reason for Recall
; Exp 4/12/15
Lot#:
12302014@9;
Exp 4/12/15
Recalling firm
Pharmacy,
L.L.C.
Class II
Lack of assurance of
sterility
Fallon
Wellness
Pharmacy,
L.L.C.
Lot#: a)
Class II
02052015@53,
Exp 4/6/15; b)
01142015@31,
Exp 3/15/15; c)
02022015@6,
Exp 4/3/15; d)
01132015@72,
Exp 3/14/15;
e)
01282015@57,
Exp 3/29/15; f)
01302015@50,
Exp 3/31/15;
g)
01232015@14,
Exp 3/24/15
Lot#: a)
Class II
02092015@59,
Exp 4/10/15;
b)
02122015@49,
Exp 4/13/15; c)
02132015@44,
Exp 4/14/15;
d)
02192015@34,
Exp 4/20/15
Lack of assurance of
sterility
Fallon
Wellness
Pharmacy,
L.L.C.
Lack of assurance of
sterility
Fallon
Wellness
Pharmacy,
L.L.C.
1) GloStrips
Lot: a) 9031,
Exp 12/17; b)
9023, Exp
Failed Content
Uniformity
Specifications: The
product may not meet
Nomax Inc
Class III
Copyright© PerformRx, LLC 2015 All Rights Reserved
204
Product
Type
Drugs
Drugs
Product
Description
strip, labeled as
1) Fluorescein
GloStrips,
individually
wrapped strip
packaged in a)
100-count strips
per carton; and b)
300-count strips
per carton; and 2)
FUL-GLO,
individually
wrapped strip,
packaged in 300count strips per
carton
Rose Bengal
GloStrips (rose
bengal)
Ophthalmic Strips
USP, 1.3 mg per
strip, individually
wrapped strip,
packaged in 100count strips per
carton
Code info.
Class
Lot #: 8925,
Exp 07/17;
8972, Exp
10/17; and
9195, Exp
04/18
Class III
Fluorescein
Sodium
Ophthalmic Strips
USP, 1.0 mg per
strip, labeled as
1) FUL-GLO,
individually
wrapped strips;
packaged in 100count strips per
carton,; and
1) FUL-GLO
Lot: 8980, Exp
10/15; 9081,
Exp 01/16;
9088, Exp
02/16; 9128
and 9158, Exp
03/16; 2) Pro
Glo Lot: 9082,
Exp 01/17
Class III
11/17; 9065,
Exp 01/18;
9127 and
9132, Exp
03/18; and 2)
Ful-Glo Lot:
9050, Exp
12/18; 9113,
Exp 02/19; and
9206, Exp
05/19
Reason for Recall
Recalling firm
finished product release
specifications, including
the uniformity of dosage
due to a packaging
degradation related to
the adhesive component
of the paper pouch that
can impact the level of
fluorescein present in
the strips.
Copyright© PerformRx, LLC 2015 All Rights Reserved
Failed Content
Uniformity
Specifications: The
product may not meet
finished product release
specifications, including
the uniformity of dosage
due to a packaging
degradation related to
the adhesive component
of the paper pouch that
can impact the level of
rose bengal present in
the strips.
Failed Content
Uniformity
Specifications: The
product may not meet
finished product release
specifications, including
the uniformity of dosage
due to a packaging
degradation related to
the adhesive component
of the paper pouch that
Nomax Inc
Nomax Inc
205
Product
Type
Drugs
Drugs
Drugs
Drugs
Product
Description
2)Fluorescein Pro
Glo Strips,
individually
wrapped strips,
packaged in 300count strips per
carton
Mucinex DM
(guaifenesin
600mg and
dextromethorpha
n HBr 30mg),
extended-release
bi-layer tablets, 2
tablets per
pouch, OTC
MONISTAT 1
SIMPLE CURE
(Miconazole
Nitrate Vaginal
Insert) 1200 mg
ovule, 1-DAY
MAXIMUM
STRENGTH
TREATMENT
OVULE per case,
over-the-counter
Olanzapine,
Orally
Disintegrating
Tablets, 5 mg, a)
30-count bottle,
b) 100-count
blister, Rx only
Olanzapine,
Orally
Disintegrating
Tablets, 10 mg, a)
30-count bottle,
b) 100-count
blister, Rx only
Code info.
Class
Reason for Recall
Recalling firm
can impact the level of
fluorescein present in
the strips.
Lot BD375 exp
06/2016;
BD566, BD661
exp. 08/2016
Class III
Defective container: A
customer complaint
revealed the presence of
a defective seal on the
top of a Mucinex pouch
Reckitt
Benckiser LLC
Lot#: R18193,
Exp 10/2016
Class III
Marketed without an
approved NDA/ANDA:
The distributed units of
Monistat 1 Simple Cure
include only the 1200 mg
vaginal suppository; the
approved NDA requires
both a 1200 mg vaginal
suppository and the 2%
topical cream.
Medtech
Products, Inc.
Subpotent drug
Apotex Inc.
Subpotent drug
Apotex Inc.
Lot #: a)
Class III
KL0655, Exp
04/15; KY2374,
Exp 05/16; b)
KL0656, Exp
04/15; KY2371,
Exp 05/16
Lot #: a)
Class III
KY2389, Exp
05/16; b)
KY2388, Exp
05/16
Copyright© PerformRx, LLC 2015 All Rights Reserved
206
Product
Type
Drugs
Product
Description
Olanzapine,
Orally
Disintegrating
Tablets, 20 mg,
30-count bottle,
Rx only
Drugs
Levalbuterol
Inhalation
Solution, USP,
0.63 mg/ 3 mL, 3
mL Vials, Rx Only.
VACCINES
Biologics NONE
Code info.
Class
Reason for Recall
Recalling firm
Lot # KL0664,
Exp 04/15
Class III
Subpotent drug
Apotex Inc.
Lot #: FA4022;
Expiry:
December
2015.
Class III
Failed
Impurities/Degradation
Specifications: Product is
out of specification for a
known degradant.
Cipla Limited
*Please refer to FDA website for further information; http://www.fda.gov/Safety/Recalls/EnforcementReports/default.htm
Copyright© PerformRx, LLC 2015 All Rights Reserved
207
CURRENT DRUG SHORTAGES‡
Bupivacaine Injection
April 29, 2015
Reason for the Shortage
 Fresenius Kabi (formerly APP) has Sensorcaine on shortage due to increased demand
for the product.
 Hospira has bupivacaine on shortage due to manufacturing delays.
 AuroMedics introduced bupivacaine injection in February 2014.
Article Link:
http://www.ashp.org/menu/DrugShortages/CurrentShortages/Bulletin.aspx?id=864
Source Link: http://www.ashp.org
Cisplatin Injection
April 29, 2015
Reason for the Shortage
 Fresenius states the shortage was due to increased demand and manufacturing delays.
 Mylan Institutional cannot provide a reason for the shortage.
 Teva was allocating cisplatin to prevent stockpiling.
 WG Critical Care was allocating product due to increased demand.
Article Link: http://www.ashp.org/menu/DrugShortages/CurrentShortages/Bulletin.aspx?id=57
Source Link: http://www.ashp.org
Leuprolide Acetate 14-Day Kit
April, 29 2015
Reason for the Shortage
 Caraco has a new NDC number for the leuprolide injection.
 Teva states the shortage is due to manufacturing delays.
Article Link:
http://www.ashp.org/menu/DrugShortages/CurrentShortages/Bulletin.aspx?id=737
Source Link: http://www.ashp.org
Copyright© PerformRx, LLC 2015 All Rights Reserved
208
Ampicillin Sulbactam
April 30, 2015
Reason for the Shortage
 AuroMedics Pharma launched new product in mid-June, 2012.
 Hospira states that ampicillin sulbactam vials are on back order due to manufacturing
delay.
 Mylan Institutional discontinued ampicillin sulbactam injection in late 2013.
 Sagent has ampicillin sulbactam vials on allocation due to increased demand for the
product.
 WG Critical Care states the shortage is due to increased demand.
 Pfizer and Sandoz cannot provide a reason for the shortage.
 WG Critical Care launched ampicillin sulbactam 1.5 gram vials in March 2014.
 West-Ward acquired several Baxter products in early 2011.
Article Link:
http://www.ashp.org/menu/DrugShortages/CurrentShortages/Bulletin.aspx?id=805
Source Link: http://www.ashp.org
Azithromycin Injection
April 30, 2015
Reason for the Shortage
 Fresenius Kabi has azithromycin on shortage due to increased demand.
 Hospira has azithromycin injection on shortage due to manufacturing delays.
 Sagent had azithromycin injection on shortage due to manufacturing delays.
 Pfizer had Zithromax injection on shortage due to increased demand.
Article Link:
http://www.ashp.org/menu/DrugShortages/CurrentShortages/Bulletin.aspx?id=936
Source Link: http://www.ashp.org
Benztropine Injection
April 30, 2015
Reason for the Shortage
 American Regent has benztropine injection on back order due to manufacturing delays.
 Fresenius Kabi USA recalled benztropine injection due to potential for glass particles in
the vials. Product may have been under APP or Nexus labels. Detailed information on
the recall can be found online.
Article Link:
http://www.ashp.org/menu/DrugShortages/CurrentShortages/Bulletin.aspx?id=1042
Copyright© PerformRx, LLC 2015 All Rights Reserved
209
Source Link: http://www.ashp.org
Cefotaxime Injection
April 30, 2015
Reason for the Shortage
 Hospira has discontinued Claforan. Sanofi-Aventis manufactured Claforan for Hospira
and is no longer making the product.
 Baxter has Claforan on allocation due to increased demand.
 West-Ward cannot provide a reason for the shortage.
Article Link:
http://www.ashp.org/menu/DrugShortages/CurrentShortages/Bulletin.aspx?id=826
Source Link: http://www.ashp.org
Clindamycin Injection
April 30, 2015
Reason for the Shortage
 Pfizer states the Cleocin Add-Vantage vials are on shortage due to manufacturing delays.
 Hospira has clindamycin injection on shortage due to manufacturing delays.
 Akorn launched clindamycin injection in June 2013.
 Sandoz had clindamycin injection on shortage due to increased demand.
 Sagent has clindamycin injection on shortage due to manufacturing delays.
Article Link:
http://www.ashp.org/menu/DrugShortages/CurrentShortages/Bulletin.aspx?id=1029
Source Link: http://www.ashp.org
Indigo Carmine Injection
April 30, 2015
Reason for the Shortage
 American Regent has indigo carmine on back order due to manufacturing delays.
 Akorn has discontinued production of indigo carmine due to shortage of raw material.
Article Link:
http://www.ashp.org/menu/DrugShortages/CurrentShortages/Bulletin.aspx?id=861
Source Link: http://www.ashp.org
Copyright© PerformRx, LLC 2015 All Rights Reserved
210
Labetalol Injection
April 30, 2015
Reason for the Shortage
 Hospira has labetalol on shortage due to manufacturing delays and increased demand.
 Apotex discontinued their 4 mL vials (NDC 60505-0717-00) in February, 2010. The
company could not provide a reason for the discontinuation.
 Sagent suspended production on labetalol 5 mg/mL 20 mL vials in July 2013.
 Sagent suspended production on labetalol 5 mg/mL 20 mL vials in July 2013 and 40 mL
vials in February 2014.
 West-Ward Pharmaceuticals’ parent company, Hikma Pharmaceuticals, acquired several
products from Bedford Laboratories in July 2014 including labetalol injection. WestWard is not actively marketing labetalol injection.
Article Link:
http://www.ashp.org/menu/DrugShortages/CurrentShortages/Bulletin.aspx?id=397
Source Link: http://www.ashp.org
Leucovorin Calcium Injection
April 30, 2015
Reason for the Shortage
 West-Ward Pharmaceuticals’ parent company, Hikma Pharmaceuticals, acquired
leucovorin calcium injection from Bedford in July 2014. West-Ward is not actively
marketing leucovorin calcium injection at this time.
 Teva had leucovorin on shortage due to manufacturing delays.
 Fresenius Kabi has leucovorin on shortage due to increase demand.
Article Link:
http://www.ashp.org/menu/DrugShortages/CurrentShortages/Bulletin.aspx?id=488
Source Link: http://www.ashp.org
Methylprednisolone Acetate Injection
April 30, 2015
Reason for the Shortage
 Sandoz and Teva could not provide a reason for the shortage.
 Pfizer has Depo-Medrol injection available and is supplying the market.
Article Link:
http://www.ashp.org/menu/DrugShortages/CurrentShortages/Bulletin.aspx?id=923
Source Link: http://www.ashp.org
Copyright© PerformRx, LLC 2015 All Rights Reserved
211
Nafcillin Sodium
April 30, 2015
Reason for the Shortage
 AuroMedicss and Fresenius Kabi state the reason for the shortage is increased demand.
 Sagent stated the reason for the shortage is increased demand.
 Sandoz states the reason for the shortage is internal issues.
Article Link:
http://www.ashp.org/menu/DrugShortages/CurrentShortages/Bulletin.aspx?id=1136
Source Link: http://www.ashp.org
Lidocaine Injection
May 01, 2015
Reason for the Shortage
 Amphastar had lidocaine 2% emergency syringes on shortage due to increase demand
for the product.
 AuroMedics introduced lidocaine injection in February 2014.
 Fresenius Kabi has Xylocaine and lidocaine presentations on shortage due to increased
demand for the product.
 Hospira has lidocaine presentations on shortage due to manufacturing delays and
increased demand.
Article Link:
http://www.ashp.org/menu/DrugShortages/CurrentShortages/Bulletin.aspx?id=859
Source Link: http://www.ashp.org
Liotrix Tablets
May 01, 2015
Reason for the Shortage
 Thyrolar tablets from Forest Laboratories are on back order due to manufacturing
changes.
Article Link: http://www.ashp.org/menu/DrugShortages/CurrentShortages/Bulletin.aspx?id=24
Source Link: http://www.ashp.org
Nebivolol Tablets
May 01, 2015
Reason for the Shortage
 Actavis could not provide a reason for the shortage.
Copyright© PerformRx, LLC 2015 All Rights Reserved
212
Article Link:
http://www.ashp.org/menu/DrugShortages/CurrentShortages/Bulletin.aspx?id=1137
Article Source: http://www.ashp.org
Papaverine Injection
May 01, 2015
Reason for the Shortage
 Bedford and Sandoz have discontinued their papaverine presentations.
 American Regent has papaverine on shortage due to manufacturing delays.
 American Regent is the sole supplier of papaverine.
Article Link:
http://www.ashp.org/menu/DrugShortages/CurrentShortages/Bulletin.aspx?id=781
Source Link: http://www.ashp.org
Propranolol Injection
May 01, 2015
Reason for the Shortage
 Ben Venue closed its plant in Bedford, Ohio in July 2014.
 Fresenius Kabi has propranolol injection on back order due to shortage of raw materials.
 Sandoz cannot provide a reason for the shortage.
 West-Ward has propranolol injection on shortage due to manufacturing delays.
Article Link:
http://www.ashp.org/menu/DrugShortages/CurrentShortages/Bulletin.aspx?id=1091
Source Link: http://www.ashp.org
Sodium Chloride Concentrated Solution for Injection
May 01, 2015
Reason for the Shortage
 American Regent discontinued 23.4% sodium chloride 30 mL and 100 mL presentations
in 2012.
 Baxter discontinued their sodium chloride 250 mL presentation in 2008.
 Fresenius Kabi (formerly APP) has sodium chloride concentrated solution on shortage
due to increased demand. Fresenius Kabi discontinued 14.6% sodium chloride 20 mL
vials in February 2013.
 Hospira has 14.6% and 23.4% sodium chloride solutions for injection on shortage due to
manufacturing delays. Hospira discontinued sodium chloride 14.6% solution 250 mL
vials in February 2011.
Copyright© PerformRx, LLC 2015 All Rights Reserved
213
Article Link:
http://www.ashp.org/menu/DrugShortages/CurrentShortages/Bulletin.aspx?id=724
Source Link: http://www.ashp.org
Desmopressin Injection
May 04, 2015
Reason for the Shortage
 Teva and Hospira have desmopressin injection on shortage due to manufacturing
delays.
 Ferring acquired marketing rights of DDAVP from Sanofi in October 2014.
Article Link:
http://www.ashp.org/menu/DrugShortages/CurrentShortages/Bulletin.aspx?id=1010
Source Link: http://www.ashp.org
Dextrose 5% Injection Large Volume Bags
May 04, 2015
Reason for the Shortage
 Baxter states the shortage is due to increased demand.
 BBraun had 5% dextrose on allocation due to increased demand.
 Hospira states the shortage is due to increased demand and manufacturing delays.
Article Link:
http://www.ashp.org/menu/DrugShortages/CurrentShortages/Bulletin.aspx?id=1081
Source Link: http://www.ashp.org
Doxorubicin Liposomal Injection
May 04, 2015
Reason for the Shortage
 Janssen Products, LP states the shortage is due to manufacturing issues. Janssen
Products, LP has updates with information about the shortage on the Doxil website that
is updated regularly.
 FDA approved a new manufacturer of Doxil in January 2015.
 Ben Venue has stopped production in its plant in Bedford, Ohio and closed in 2014.
 Caraco launched generic doxorubicin liposomal injection in mid-March 2013 and can
supply the market with their presentations.
Article Link:
http://www.ashp.org/menu/DrugShortages/CurrentShortages/Bulletin.aspx?id=806
Source Link: http://www.ashp.org
Copyright© PerformRx, LLC 2015 All Rights Reserved
214
Lactated Ringer’s Injection Bags
May 04, 2015
Reason for the Shortage
 Baxter has lactated ringers on shortage due to increased demand.
 BBraun has lactated ringers on allocation due to increased demand.
 Hospira cited increased demand as the reason for the shortage.
Article Link:
http://www.ashp.org/menu/DrugShortages/CurrentShortages/Bulletin.aspx?id=1078
Source Link: http://www.ashp.org
Promethazine Injection
May 04, 2015
Reason for the Shortage
 Teva states the shortage is due to manufacturing delays.
 West-Ward states the shortage was due to manufacturing delays. The company has also
changed the NDC numbers for products that were formerly Baxter products.
 Hospira states the shortage is due to manufacturing delays.
Article Link:
http://www.ashp.org/menu/DrugShortages/CurrentShortages/Bulletin.aspx?id=654
Source Link: http://www.ashp.org
Sodium Bicarbonate Injection
May 04, 2015
Reason for the Shortage
 Hospira has sodium bicarbonate on back order due to increased demand.
 Amphastar had sodium bicarbonate on back order due to increased demand.
Article Link:
http://www.ashp.org/menu/DrugShortages/CurrentShortages/Bulletin.aspx?id=788
Source Link: http://www.ashp.org
Sodium Chloride 0.9% Irrigation
May 04, 2015
Reason for the Shortage
 Baxter has 0.9% sodium chloride irrigation on shortage due manufacturing delays.
 BBraun has 0.9% sodium chloride irrigation on shortage due to increased demand and
only has product available for existing customers.
Copyright© PerformRx, LLC 2015 All Rights Reserved
215

Hospira has 0.9% sodium chloride irrigation on shortage due manufacturing delays and
only has product available for existing customers.
Article Link:
http://www.ashp.org/menu/DrugShortages/CurrentShortages/Bulletin.aspx?id=1118
Source Link: http://www.ashp.org
Sufentanil Injection
May 04, 2015
Reason for the Shortage
 West-Ward had sufentanil on shortage due to manufacturing delays.
 Hospira has sufentanil on shortage due to manufacturing delays.
 Akorn could not provide a reason for the shortage.
Article Link:
http://www.ashp.org/menu/DrugShortages/CurrentShortages/Bulletin.aspx?id=823
Source Link: http://www.ashp.org
Thiotepa for Injection
May 04, 2015
Reason for the Shortage
 West-Ward Pharmaceuticals’ parent company, Hikma Pharmaceuticals, acquired several
products from Bedford Laboratories in July 2014 including thiotepa injection. WestWard is not actively marketing thiotepa injection at this time.
 FDA is allowing temporary importation of Tepadina (thiotepa), from Adienne Srl in Italy.
Product may be ordered directly through Adienne Srl. The solution is similar in
formulation to US thiotepa. The main differences between the two products are listed
below:
 Tepadina comes in 15 mg and 100 mg vials while the US thiotepa from Bedford only
comes in a 15 mg vial. Reconstitution of the products should still yield a final
concentration of 10 mg/mL and therefore use caution in choosing vial size and volume
of diluent.
 Tepadina is indicated for different uses and therefore different dosing regimens are on
the Europe labeling compared to US labeling, but it is the same product as in the US.
 The bar coding for the Italian product will not provide correct information to bar code
readers since the manufacturing code is not an NDC number. More information on the
product packaging and ordering procedures can be found online.
 Adienne Srl is supplying Tepadina directly to hospitals and not through wholesalers.
Orders can be placed directly with Adienne. Orders are shipped Monday through
Copyright© PerformRx, LLC 2015 All Rights Reserved
216

Wednesday to ensure product can arrive prior to the weekend to prevent temperature
deviations.
There are no other manufacturers of thiotepa for injection.
Article Link:
http://www.ashp.org/menu/DrugShortages/CurrentShortages/Bulletin.aspx?id=589
Source Link: http://www.ashp.org
Trypan Blue 0.15% Ophthalmic Solution
May 04, 2015
Reason for the Shortage
 Dutch Ophthalmic has MembraneBlue on shortage due to difficulty in obtaining raw
materials.
 There are no other manufacturers of trypan blue.
 Dutch Ophthalmic has VisionBlue 0.06% ophthalmic solution available (NDC 688030612-10). VisionBlue is used as an adjunct in cataract surgery.
Article Link:
http://www.ashp.org/menu/DrugShortages/CurrentShortages/Bulletin.aspx?id=1145
Source Link: http://www.ashp.org
Atropine Sulfate Injection
May 05, 2015
Reason for the Shortage
 American Regent states the shortage was due to manufacturing delays.
 Hospira states the shortage is due to manufacturing delays.
 Amphastar has atropine on shortage due to increased demand.
Article Link:
http://www.ashp.org/menu/DrugShortages/CurrentShortages/Bulletin.aspx?id=814
Source Link: http://www.ashp.org
Castor Oil, Balsam Peru, and Trypsin Topical Products
May 05, 2015
Reason for the Shortage
 Stratus Pharmaceuticals discontinued Vasolex ointment in April 2015.
 Smith & Nephew discontinued Xenaderm ointment in August 2013.
 Prasco discontinued Revina ointment in August 2011.
Copyright© PerformRx, LLC 2015 All Rights Reserved
217

Products containing only castor oil and balsam peru are not affected by this shortage.
Examples include Venelex ointment in 60 gram tubes (NDC 58980-0780-21) from Stratus
and Proderm topical spray in 113.4 grams cans (NDC 51079-0622-82) from Mylan.
Article Link:
http://www.ashp.org/menu/DrugShortages/CurrentShortages/Bulletin.aspx?id=1179
Source Link: http://www.ashp.org
Cefotetan Disodium Injection
May 05, 2015
Reason for the Shortage
 BBraun could not provide a reason for the shortage.
 Fresenius Kabi states the reason for the shortage is manufacturing delay.
Article Link:
http://www.ashp.org/menu/DrugShortages/CurrentShortages/Bulletin.aspx?id=1097
Source Link: http://www.ashp.org
Ceftazidime Injection
May 05, 2015
Reason for the Shortage
 Covis had Fortaz premixed bags on shortage due to increased demand.
 Hospira had ceftazidime on shortage due to manufacturing delays.
 Sagent has ceftazidime injection on shortage due to increased demand for the product.
Article Link:
http://www.ashp.org/menu/DrugShortages/CurrentShortages/Bulletin.aspx?id=869
Source Link: http://www.ashp.org
Acamprosate Calcium Tablets
May 06, 2015
Reason for the Shortage
 Glenmark Pharmaceuticals cannot provide a reason for the shortage.
 Mylan cannot provide a reason for the shortage.
 Actavis discontinued Campral tablets in 2014.
Article Link:
http://www.ashp.org/menu/DrugShortages/CurrentShortages/Bulletin.aspx?id=1170
Source Link: http://www.ashp.org
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218
Benzonatate Capsules
May 06, 2015
Reason for the Shortage
 Amneal and Ascend Laboratories cannot provide a reason for the shortage.
 Caraco will discontinue benzonatate capsules when current supplies are depleted.
 Zydus states the reason for the shortage is manufacturing delay.
 Pfizer has Tessalon Perles on shortage due to supply and demand issues.
Article Link:
http://www.ashp.org/menu/DrugShortages/CurrentShortages/Bulletin.aspx?id=1155
Source Link: http://www.ashp.org
Daunorubicin Hydrochloride Injection
May 06, 2015
Reason for the Shortage
 West-Ward Pharmaceuticals’ parent company, Hikma Pharmaceuticals, acquired
daunorubicin injection and Cerubidine injection from Bedford in July 2014. West-Ward
is not actively marketing daunorubicin injection or Cerubidine injection at this time.
 Teva’s daunorubicin injection has a 12 month shelf-life after manufacturing.
 Teva states daunorubicin was on back order due to manufacturing delays.
Article Link:
http://www.ashp.org/menu/DrugShortages/CurrentShortages/Bulletin.aspx?id=1007
Source Link: http://www.ashp.org
Diltiazem Injection
May 06, 2015
Reason for the Shortage
 Ben Venue stopped production in its plant in Bedford, Ohio and closed in July 2014.
 Hospira states the reasons for the shortage are manufacturing delays and increases in
demand.
 West-Ward had diltiazem injection on shortage due to manufacturing delays caused by
increased demand due to current market conditions.
 Akorn states the reason for the shortage is increased demand due to market conditions.
 Teva discontinued all diltiazem presentations in March, 2011.
 Biovail discontinued Cardizem Lyo-Ject in 2007 due to business reasons.
Article Link:
http://www.ashp.org/menu/DrugShortages/CurrentShortages/Bulletin.aspx?id=217
Source Link: http://www.ashp.org
Copyright© PerformRx, LLC 2015 All Rights Reserved
219
Ethambutol Tablets
May 06, 2015
Reason for the Shortage
 Akorn acquired VersaPharm, Inc. in 2014.
 Akorn could not provide a reason for the shortage.
 X-Gen could not provide a reason for the shortage.
 G&W Laboratories discontinued ethambutol tablets in mid-April 2013.
Article Link:
http://www.ashp.org/menu/DrugShortages/CurrentShortages/Bulletin.aspx?id=982
Source Link: http://www.ashp.org
Methylphenidate Hydrochloride Extended Release Oral Presentations
May 06, 2015
Reason for the Shortage
 Mallinckrodt states the shortage was due to delay in obtaining raw materials.
 Teva introduced generic methylphenidate extended release capsules (CD) in lateSeptember 2012, and these capsules are AB-rated to Metadate CD capsules.
 Actavis states the shortage of methylphenidate is due to increased demand. Actavis
estimates a shortage of methylphenidate ER tablets will begin in December 2014 and
last through 2nd quarter 2015.
 UCB states methylphenidate ER tablets were on shortage due to supply and demand.
 Janssen states the shortage of Concerta is due to increased demand. Janssen estimates
a shortage of Concerta will begin in December 2014 and last through 2nd quarter 2015.
 Novartis discontinued Ritalin SR in October 2014.
Article Link:
http://www.ashp.org/menu/DrugShortages/CurrentShortages/Bulletin.aspx?id=1166
Source Link: http://www.ashp.org
Sodium Chloride 0.45% Injection Bags
May 06, 2015
Reason for the Shortage
 Baxter had 0.45% sodium chloride on shortage due to increased demand.
 BBraun has 0.45% sodium chloride on allocation due to increased demand.
 Hospira cited increased demand as the reason for the shortage.
Article Link:
http://www.ashp.org/menu/DrugShortages/CurrentShortages/Bulletin.aspx?id=1083
Source Link: http://www.ashp.org
Copyright© PerformRx, LLC 2015 All Rights Reserved
220
Ammonium Chloride Injection
May 07, 2015
Reason for the Shortage
 Hospira states the shortage of ammonium chloride is due to manufacturing delays.
 Hospira is the sole manufacturer of ammonium chloride injection.
Article Link:
http://www.ashp.org/menu/DrugShortages/CurrentShortages/Bulletin.aspx?id=933
Source Link: http://www.ashp.org
Hydralazine Injection
May 07, 2015
Reason for the Shortage
 Akorn has hydralazine injection on shortage due to increased demand.
 American Regent has hydralazine injection on shortage due to manufacturing delays.
 Fresenius Kabi has hydralazine injection on shortage due to manufacturing delays.
Article Link:
http://www.ashp.org/menu/DrugShortages/CurrentShortages/Bulletin.aspx?id=1129
Source Link: http://www.ashp.org
Valproate Sodium Injection
May 07, 2015
Reason for the Shortage
 Fresenius Kabi states the reason for the shortage is manufacturing delay.
 West-Ward cannot provide a reason for the shortage.
Article Link:
http://www.ashp.org/menu/DrugShortages/CurrentShortages/Bulletin.aspx?id=842
Source Link: http://www.ashp.org
Aminohippurate Sodium
May 08, 2015
Reason for the Shortage
 Merck cannot provide a reason for the shortage.
Article Link:
http://www.ashp.org/menu/DrugShortages/CurrentShortages/Bulletin.aspx?id=1135
Source Link: http://www.ashp.org
Copyright© PerformRx, LLC 2015 All Rights Reserved
221
Ceftriaxone Sodium Injection
May 08, 2015
Reason for the Shortage
 Ben Venue stopped production in its plant in Bedford, Ohio and closed in July 2014.
 Fresenius Kabi states the reason for the shortage is increased demand.
 Hospira states the reason for the shortage is manufacturing delay.
 Sagent states the reason for the shortage is increased demand.
 Sandoz could not provide a reason for the shortage.
 WG Critical Care states the reason for the shortage is increased demand.
Article Link:
http://www.ashp.org/menu/DrugShortages/CurrentShortages/Bulletin.aspx?id=1101
Source Link: http://www.ashp.org
Cefuroxime Sodium Injection
May 08, 2015
Reason for the Shortage
 Sagent states manufacture of cefuroxime 1.5 gram was suspended in March, 2013. No
further production is planned.
 Hospira discontinued cefuroxime 1.5 gram and 7.5 gram vials in January, 2013.
 Covis launched the new NDC numbers in August 2013.
 BBraun discontinued their cefuroxime solution in December 2013.
 Fresenius Kabi discontinued manufacturing cefuroxime in 2013.
Article Link:
http://www.ashp.org/menu/DrugShortages/CurrentShortages/Bulletin.aspx?id=990
Source Link: http://www.ashp.org
Chlorothiazide Oral Suspension
May 08, 2015
Reason for the Shortage
 Valeant cannot provide a reason for the shortage.
 Valeant recently acquired Diuril oral suspension from Salix.
Article Link:
http://www.ashp.org/menu/DrugShortages/CurrentShortages/Bulletin.aspx?id=1076
Source Link: http://www.ashp.org
Copyright© PerformRx, LLC 2015 All Rights Reserved
222
Cytarabine Injection
May 08, 2015
Reason for the Shortage
 Fresenius Kabi has cytarabine on shortage due to increased demand.
 Mylan Institutional cannot provide a reason for the shortage.
 West-Ward is not currently marketing cytarabine.
Article Link:
http://www.ashp.org/menu/DrugShortages/CurrentShortages/Bulletin.aspx?id=413
Source Link: http://www.ashp.org
Deferoxamine Mesylate Injection
May 08, 2015
Reason for the Shortage
 Fresenius Kabi states the shortage was due to increased demand.
 Hospira has deferoxamine on shortage due to increased demand.
 Teva discontinued all deferoxamine presentations in 2013.
 West-Ward Pharmaceuticals’ parent company, Hikma Pharmaceuticals, acquired
deferoxamine injection from Bedford in July 2014. West-Ward is not actively marketing
deferoxamine injection at this time.
 Watson discontinued all deferoxamine presentations.
Article Link:
http://www.ashp.org/menu/DrugShortages/CurrentShortages/Bulletin.aspx?id=1008
Source Link: http://www.ashp.org
Digoxin Injection
May 08, 2015
Reason for the Shortage
 West-Ward states the shortage is due to manufacturing delays.
Article Link:
http://www.ashp.org/menu/DrugShortages/CurrentShortages/Bulletin.aspx?id=748
Source Link: http://www.ashp.org
L-Cysteine Hydrochloride Injection
May 08, 2015
Reason for the Shortage
 American Regent has L-cysteine hydrochloride injection on back order due to
manufacturing delays.
Copyright© PerformRx, LLC 2015 All Rights Reserved
223

Sandoz cannot provide a reason for the shortage.
Article Link:
http://www.ashp.org/menu/DrugShortages/CurrentShortages/Bulletin.aspx?id=632
Source Link: http://www.ashp.org
Memantine Hydrochloride
May 08, 2015
Reason for the Shortage
 Forest states the reason for the shortage of Namenda XR capsules is manufacturing
delay.
Article Link:
http://www.ashp.org/menu/DrugShortages/CurrentShortages/Bulletin.aspx?id=1082
Source Link: http://www.ashp.org
Metronidazole Injection
May 08, 2015
Reason for the Shortage
 Hospira had metronidazole injection on back order due to manufacturing delays.
 BBraun was allocating metronidazole injection due to increased demand for the
product.
Article Link:
http://www.ashp.org/menu/DrugShortages/CurrentShortages/Bulletin.aspx?id=643
Source Link: http://www.ashp.org
Ranitidine Injection
May 08, 2015
Reason for the Shortage
 West-Ward Pharmaceuticals’ parent company, Hikma Pharmaceuticals, acquired
ranitidine injection from Bedford in July 2014. West-Ward is not actively marketing
ranitidine injection.
 Covis has Zantac on shortage due to capacity issues at the manufacturer.
 Oral ranitidine products are not affected by this shortage.
Article Link:
http://www.ashp.org/menu/DrugShortages/CurrentShortages/Bulletin.aspx?id=820
Source Link: http://www.ashp.org
Copyright© PerformRx, LLC 2015 All Rights Reserved
224
Rocuronium Injection
May 08, 2015
Reason for the Shortage
 Merck discontinued Zemuron 10 mL multidose vials in the 3rd Quarter of 2013. Merck
discontinued Zemuron 5 mL vials in June 2014.
 Mylan Institutional states the reason for the shortage is increased demand.
 Hospira has rocuronium on shortage due to manufacturing delays.
 Teva has rocuronium on shortage due to manufacturing delays.
 Fresenius Kabi and Sagent cited increased demand as the reason for this shortage.
 Sandoz could not provide a reason for the shortage.
 The Medicines Company launched rocuronium in early 2014.
 X-Gen has rocuronium injection on short-term back order.
Article Link:
http://www.ashp.org/menu/DrugShortages/CurrentShortages/Bulletin.aspx?id=434
Source Link: http://www.ashp.org
Caffeine Citrate Injection and Oral Solution
May 11, 2015
Reason for the Shortage
 American Regent has caffeine citrate on shortage due to manufacturing delays.
 Caraco discontinued caffeine citrate oral solution in mid-2015.
 Paddock discontinued caffeine citrate injection and oral solution in May 2014.
 Sagent states the reason for the shortage is manufacturing delays.
 West-Ward Pharmaceuticals’ parent company, Hikma Pharmaceuticals, acquired Cafcit
from Bedford in July 2014. West-Ward is actively marketing Cafcit injection.
Article Link:
http://www.ashp.org/menu/DrugShortages/CurrentShortages/Bulletin.aspx?id=862
Source Link: http://www.ashp.org
Calcium Chloride Injection
May 11, 2015
Reason for the Shortage
 American Regent has calcium chloride on shortage due to manufacturing delays.
 Amphastar had calcium chloride on shortage due to increased demand.
 Hospira has calcium chloride on shortage due to manufacturing delays.
 Mylan Institutional cannot provide a reason for the shortage.
Copyright© PerformRx, LLC 2015 All Rights Reserved
225
Article Link:
http://www.ashp.org/menu/DrugShortages/CurrentShortages/Bulletin.aspx?id=941
Source Link: http://www.ashp.org
Dextrose (50%) Injection
May 11, 2015
Reason for the Shortage
 Hospira states the shortage is due to increased demand.
Article Link:
http://www.ashp.org/menu/DrugShortages/CurrentShortages/Bulletin.aspx?id=1012
Source Link: http://www.ashp.org
Haloperidol Decanoate Injection
May 11, 2015
Reason for the Shortage
 Teva products are on shortage due to manufacturing delays.
 Fresenius Kabi could not provide a reason for the shortage.
 West-Ward Pharmaceuticals’ parent company, Hikma Pharmaceuticals, acquired
haloperidol decanoate injection from Bedford in July 2014. West-Ward is not actively
marketing haloperidol decanoate injection at this time.
Article Link:
http://www.ashp.org/menu/DrugShortages/CurrentShortages/Bulletin.aspx?id=526
Source Link: http://www.ashp.org
Ketorolac Tromethamine Injection
May 11, 2015
Reason for the Shortage
 Fresenius Kabi states the shortage was due to manufacturing delays.
 Hospira has ketorolac on shortage due to manufacturing delays for quality improvement
activities and increased demand for the product.
 Hospira issued a voluntary recall of several presentations of ketorolac in January 2015
due to potential for particulate matter.
 Sagent states the reason for the shortage is demand exceeding supply.
 West-Ward has ketorolac injection on shortage due to manufacturing delays.
 Ben Venue closed its plant in Bedford, Ohio in July 2014.
 FDA imposed an import ban in mid-2013 on several Wockhardt products including
ketorolac.
 Sprix Nasal Spray is not affected by this shortage.
Copyright© PerformRx, LLC 2015 All Rights Reserved
226
Article Link:
http://www.ashp.org/menu/DrugShortages/CurrentShortages/Bulletin.aspx?id=593
Source Link: http://www.ashp.org
Lidocaine with Epinephrine Injection
May 11, 2015
Reason for the Shortage
 Fresenius Kabi has Xylocaine with epinephrine presentations on shortage due to
increased demand for the product.
 Hospira has lidocaine with epinephrine presentations on shortage due to manufacturing
delays and increased demand.
Article Link:
http://www.ashp.org/menu/DrugShortages/CurrentShortages/Bulletin.aspx?id=860
Source Link: http://www.ashp.org
Metoprolol Injection
May 11, 2015
Reason for the Shortage
 American Regent has metoprolol injection on shortage due to manufacturing delays.
 Ben Venue stopped production in its plant in Bedford, Ohio and closed in July 2014.
 Claris has metoprolol injection available.
 Fresenius Kabi states the shortage is due to increased demand for the product.
 Hospira states the shortage is due to increased demand for the product.
 Novartis has Lopressor injection available.
 Sagent states the shortage is due to increased demand for the product.
 Sandoz cannot provide a reason for the shortage.
 West-Ward had metoprolol injection available.
Article Link:
http://www.ashp.org/menu/DrugShortages/CurrentShortages/Bulletin.aspx?id=813
Source Link: http://www.ashp.org
Morphine Injections
May 11, 2015
Reason for the Shortage
 Fresenius Kabi states the shortage is due to a change in manufacturing sites and cannot
estimate when Astramorph will return.
 Hospira states the shortage is due to manufacturing delays.
 West-Ward states the shortage was due to increased demand for product.
Copyright© PerformRx, LLC 2015 All Rights Reserved
227
Article Link:
http://www.ashp.org/menu/DrugShortages/CurrentShortages/Bulletin.aspx?id=664
Source Link: http://www.ashp.org
Piperacillin Tazobactam Injection
May 11, 2015
Reason for the Shortage
 Apotex has piperacillin/tazobactam on shortage due to regulatory delays.
 AuroMedics and Sandoz could not provide a reason for the shortage.
 Baxter has Zosyn frozen premixes on allocation due to increased demand.
 Fresenius Kabi has piperacillin/tazobactam on shortage due to increased demand.
 Hospira has piperacillin/tazobactam on shortage due to manufacturing delays.
 Sagent has piperacillin/tazobactam on shortage due to increased demand.
 Pfizer has Zosyn on shortage due to manufacturing delays. Pfizer estimates there will be
supply shortages through September 2015 for the single dose vials and 1st quarter 2017
for the bulk vials.
 WG Critical Care states the reason for the shortage is increased demand.
Article Link:
http://www.ashp.org/menu/DrugShortages/CurrentShortages/Bulletin.aspx?id=1075
Source Link: http://www.ashp.org
Potassium Chloride Injection
May 11, 2015
Reason for the Shortage
 Hospira states the reason for the shortage is manufacturing delays.
 Fresenius Kabi and Baxter could not provide a reason for the shortage.
Article Link:
http://www.ashp.org/menu/DrugShortages/CurrentShortages/Bulletin.aspx?id=696
Source Link: http://www.ashp.org
Reteplase Injection
May 11, 2015
Reason for the Shortage
 Chiesi USA acquired Cornerstone Therapeutics in March 2014.
 Cornerstone Therapeutics acquired EKR Therapeutics in June 2012. EKR Therapeutics
had previously purchased Retavase from PDL BioPharma.
 Cornerstone Therapeutics was seeking FDA approval of a new supplier of the active
pharmaceutical ingredient for Retevase.
Copyright© PerformRx, LLC 2015 All Rights Reserved
228
Article Link:
http://www.ashp.org/menu/DrugShortages/CurrentShortages/Bulletin.aspx?id=569
Source Link: http://www.ashp.org
Succinylcholine chloride Injection
May 11, 2015
Reason for the Shortage
 Hospira had Quelicin on shortage due to manufacturing delays. Hospira discontinued
Quelicin 100 mg/mL 10 mL vials in early 2014.
 Sandoz had Anectine on shortage due to extra quality reviews.
Article Link:
http://www.ashp.org/menu/DrugShortages/CurrentShortages/Bulletin.aspx?id=582
Source Link: http://www.ashp.org
Testosterone Cypionate Intramuscular Injection
May 11, 2015
Reason for the Shortage
 Actavis discontinued testosterone cypionate injection in 2015.
 Paddock has testosterone on shortage due to increased demand and shipping delays
from their contract manufacturer.
 West-Ward had testosterone cypionate on shortage due to manufacturing delays.
 Sandoz discontinued testosterone cypionate 200 mg/mL 1 mL and 10 mL vials in
September 2011. Sandoz discontinued final presentation in first half of 2012.
 Sun Pharmaceuticals could not provide a reason for the shortage.
Article Link:
http://www.ashp.org/menu/DrugShortages/CurrentShortages/Bulletin.aspx?id=638
Source Link: http://www.ashp.org
Zinc Injection
May 11, 2015
Reason for the Shortage
 Hospira states the shortage of zinc chloride injection was due to manufacturing delays.
 American Regent states the shortage of zinc sulfate injection is due to manufacturing
delays.
Article Link:
http://www.ashp.org/menu/DrugShortages/CurrentShortages/Bulletin.aspx?id=777
Source Link: http://www.ashp.org
Copyright© PerformRx, LLC 2015 All Rights Reserved
229
Vancomycin Hydrochloride Injection
May 12, 2015
Reason for the Shortage
 Hospira has vancomycin on shortage due to increased demand.
 Fresenius Kabi has vancomycin injection on shortage due to increased demand.
 Mylan Institutional cannot provide a reason for the shortage.
 Baxter is allocating vancomycin.
 Sagent has vancomycin injection on allocation due to increased demand.
Article Link:
http://www.ashp.org/menu/DrugShortages/CurrentShortages/Bulletin.aspx?id=132
Source Link: http://www.ashp.org
Cefepime Injection
May 12, 2015
Reason for the Shortage
 Apotex could not provide a reason for the shortage.
 Fresenius Kabi has cefepime injection on shortage due to manufacturing delays.
 Sagent has cefepime injection on shortage due to increased demand.
 Sandoz cannot provide a reason for the shortage.
 Hospira has Maxipime on shortage due to manufacturing delays.
Article Link:
http://www.ashp.org/menu/DrugShortages/CurrentShortages/Bulletin.aspx?id=1176
Source Link: http://www.ashp.org
70% Dextrose Injection Large Volume Bags
May 12, 2015
Reason for the Shortage
 Baxter discontinued 70% dextrose 500 mL in 1000 mL partial-fill bags in late-2014.
 Baxter and BBraun state the reason for the shortage is increased demand for product.
 Hospira has product available.
Article Link:
http://www.ashp.org/menu/DrugShortages/CurrentShortages/Bulletin.aspx?id=1133
Source Link: http://www.ashp.org
Copyright© PerformRx, LLC 2015 All Rights Reserved
230
Sodium Phosphate Injection
May 13, 2015
Reason for the Shortage
 American Regent has sodium phosphate injection on back order due to manufacturing
delays.
 American Regent has issued a statement that all lots of sodium phosphate have
potential for crystallization. Do not use if any particles are present.
 Hospira had sodium phosphate injection on shortage due to manufacturing delays.
 In cooperation with FDA, Fresenius Kabi USA is providing Glycophos (sodium
glycerophosphate) injection to the US market to help alleviate the shortage. Glycophos
is manufactured in an FDA-approved facility in Norway by Fresenius Kabi AG.
 Fresenius Kabi launched sodium phosphate injection in mid-January 2014.
Article Link:
http://www.ashp.org/menu/DrugShortages/CurrentShortages/Bulletin.aspx?id=770
Source Link: http://www.ashp.org
Pantoprazole Tablets
May 13, 2015
Reason for the Shortage
 Actavis, Aurobindo, and Mylan could not provide a reason for the shortage.
 Actavis discontinued pantoprazole 20 mg tablets in October 2014.
 Kremers Urban state the shortage is due to increased demand.
 FDA imposed an import ban in mid-2013 on several Wockhardt products including
pantoprazole.
Article Link:
http://www.ashp.org/menu/DrugShortages/CurrentShortages/Bulletin.aspx?id=979
Source Link: http://www.ashp.org
Ondansetron Injection
May 13, 2015
Reason for the Shortage
 AuroMedics did not provide a reason for the shortage.
 Caraco temporarily discontinued ondansetron injection.
 Ben Venue stopped production in its plant in Bedford, Ohio and closed in July, 2014.
 Fresenius Kabi has ondansetron injection on back order due to increased demand.
 Heritage cannot provide a reason for the shortage.
 Sagent has ondansetron on back order due to increased demand.
 Teva re-launched ondansetron 20 mL injection in 2015.
 West-Ward had ondansetron on back order due to increased demand.
Copyright© PerformRx, LLC 2015 All Rights Reserved
231


Wockhardt has ondansetron injection on an FDA import alert.
All presentations of ondansetron 32 mg/50 mL premixed bags have been discontinued.
Article Link:
http://www.ashp.org/menu/DrugShortages/CurrentShortages/Bulletin.aspx?id=1040
Source Link: http://www.ashp.org
Methyldopate Injection
May 13, 2015
Reason for the Shortage
 American Regent has methyldopate injection on shortage due to manufacturing delays.
 There are no other suppliers of methyldopate injection.
Article Link:
http://www.ashp.org/menu/DrugShortages/CurrentShortages/Bulletin.aspx?id=844
Source Link: http://www.ashp.org
Imipenem Cilastatin Injection
May 13, 2015
Reason for the Shortage
 Fresenius has imipenem-cilastatin injection on shortage due to short expiration dating.
 Hospira has imipenem-cilastatin injection on shortage due to manufacturing delays.
 Merck cannot provide a reason for the shortage of Primaxin injection.
Article Link:
http://www.ashp.org/menu/DrugShortages/CurrentShortages/Bulletin.aspx?id=1182
Source Link: http://www.ashp.org
Ezetimibe and Atorvastatin Tablets
May 13, 2015
Reason for the Shortage
 In January 2014, Merck recalled all Liptruzet lots from wholesalers due to packaging
defects in the outer laminate foil pouches.
Article Link:
http://www.ashp.org/menu/DrugShortages/CurrentShortages/Bulletin.aspx?id=1084
Source Link: http://www.ashp.org
Copyright© PerformRx, LLC 2015 All Rights Reserved
232
Chloramphenicol Sodium Succinate Injection
May 13, 2015
Reason for the Shortage
 Fresenius Kabi has chloramphenicol injection on back order due to a raw material
shortage.
 Fresenius Kabi is the sole supplier of chloramphenicol injection.
Article Link:
http://www.ashp.org/menu/DrugShortages/CurrentShortages/Bulletin.aspx?id=1068
Source Link: http://www.ashp.org
Cefazolin Injection
May 13, 2015
Reason for the Shortage
 Fresenius Kabi, BBraun, West-Ward, and WG Critical Care have cefazolin on shortage
due to increased demand.
 WG Critical Care has cefazolin on shortage due to increased demand. WG Critical Care is
not producing cefazolin 20 gram to focus on other strengths.
 Apotex and Sandoz have cefazolin on shortage due to manufacturing delays.
 Hospira has cefazolin on shortage due to manufacturing delays.
 Sagent has cefazolin on shortage due to manufacturing delays.
Article Link:
http://www.ashp.org/menu/DrugShortages/CurrentShortages/Bulletin.aspx?id=987
Source Link: http://www.ashp.org
Azathioprine Tablets
May 13, 2015
Reason for the Shortage
 Roxane discontinued azathioprine tablets in mid-January 2015 due to problems
obtaining active ingredient.
 Valeant acquired Salix Pharmaceuticals in April 2015.
 Zydus cannot provide a reason for the shortage. Prometheus Laboratories states the
reason for the shortage was increased demand.
Article Link:
http://www.ashp.org/menu/DrugShortages/CurrentShortages/Bulletin.aspx?id=1123
Source Link: http://www.ashp.org
Copyright© PerformRx, LLC 2015 All Rights Reserved
233
Acyclovir Suspension
May 13, 2015
Reason for the Shortage
 Prestium has a new NDC number for acyclovir suspension.
Article Link:
http://www.ashp.org/menu/DrugShortages/CurrentShortages/Bulletin.aspx?id=1018
Source Link: http://www.ashp.org
Acyclovir Injection
May 13, 2015
Reason for the Shortage
 Fresenius Kabi (formerly APP) is not manufacturing acyclovir lyophilized powder to
concentrate on supplying the solution for injection.1
 Ben Venue stopped production in its plant in Bedford, Ohio and closed in July 2014.2
 AuroMedics introduced acyclovir injection in February 2014.
Article Link:
http://www.ashp.org/menu/DrugShortages/CurrentShortages/Bulletin.aspx?id=467
Source Link: http://www.ashp.org
Divalproex Sodium Delayed Release Tablets
May 14, 2015
Reason for the Shortage
 Aurobindo, Dr. Reddy’s Laboratories, Lupin, and Qualitest discontinued divalproex
sodium delayed release tablets.
 Upsher-Smith had divalproex sodium on long-term back order due to manufacturing
delay. Upsher-Smith has transitioned to new NDC numbers.
 Zydus has divalproex sodium delayed-release tablets on allocation due to increased
demand.
Article Link:
http://www.ashp.org/menu/DrugShortages/CurrentShortages/Bulletin.aspx?id=1124
Source Link: http://www.ashp.org
Dexrazoxane Injection
May 14, 2015
Reason for the Shortage
 West-Ward Pharmaceuticals’ parent company, Hikma Pharmaceuticals, acquired
dexrazoxane injection from Bedford in July 2014. West-Ward is not actively marketing
dexrazoxane injection at this time.
Copyright© PerformRx, LLC 2015 All Rights Reserved
234



Biocodex USA acquired Totect from Apricus Pharmaceuticals in April 2013.
Apricus Pharmaceuticals acquired Topotarget USA in late 2011.
Topotarget worked with FDA to extend the expiration date of specific batch numbers of
Totect to 36 months. Information regarding this extension and the batch numbers can
be found in four Dear Healthcare Customer letters available online.
Article Link:
http://www.ashp.org/menu/DrugShortages/CurrentShortages/Bulletin.aspx?id=415
Source Link: http://www.ashp.org
Carbidopa and Levodopa Extended-Release Tablets
May 14, 2015
Reason for the Shortage
 Caraco could not provide a reason for the shortage.
 Accord Healthcare could not provide a reason for the shortage.
Article Link:
http://www.ashp.org/menu/DrugShortages/CurrentShortages/Bulletin.aspx?id=1181
Source Link: http://www.ashp.org
Bupropion Hydrochloride 24 hour ER Tablets
May 14, 2015
Reason for the Shortage
 Actavis began transitioning to new NDC numbers in February 2015.
 Par states the reason for the shortage was increased demand for product.
Article Link:
http://www.ashp.org/menu/DrugShortages/CurrentShortages/Bulletin.aspx?id=1106
Source Link: http://www.ashp.org
Anagrelide Capsules
May 14, 2015
Reason for the Shortage
 Mylan discontinued anagrelide capsules in 2015.
Article Link:
http://www.ashp.org/menu/DrugShortages/CurrentShortages/Bulletin.aspx?id=1156
Source Link: http://www.ashp.org
Copyright© PerformRx, LLC 2015 All Rights Reserved
235
Amino Acid Products
May 14, 2015
Reason for the Shortage
 Baxter is unable to provide a reason for the shortage.
 BBraun has Plenamine and TrophAmine on allocation due to increased demand.
 Hospira has amino acid products on back order due to manufacturing delays.
Article Link:
http://www.ashp.org/menu/DrugShortages/CurrentShortages/Bulletin.aspx?id=671
Source Link: http://www.ashp.org
Midazolam Injections
May 15, 2015
Reason for the Shortage
 West-Ward acquired Baxter’s midazolam injection products in May, 2011.
 Ben Venue stopped production in its plant in Bedford, Ohio and closed in 2014.
 Hospira has midazolam on shortage due to manufacturing delays and demand
exceeding supply due to current market conditions.
 Hospira discontinued midazolam 5 mg/mL 1 mL iSecure syringes in July 2011.
 Fresenius Kabi (formerly APP) had midazolam on shortage due to increased demand.
 Due to low demand, Akorn is focusing on other medications that are in greater need of
supply.
 Sagent has midazolam on shortage due to manufacturing delay.
 Caraco discontinued two midazolam presentations in 2014.
 FDA imposed an import ban in mid-2013 on several Wockhardt products including
midazolam injection.
 Medicines Company has midazolam on shortage due to short-dated product.
 BD RX introduced midazolam injection in 2014.
Article Link:
http://www.ashp.org/menu/DrugShortages/CurrentShortages/Bulletin.aspx?id=858
Source Link: http://www.ashp.org
Methylene Blue Injection
May 15, 2015
Reason for the Shortage
 Akorn has methylene blue on back order due to manufacturing delays.
 American Regent has methylene blue on back order due to manufacturing delays.
Article Link:
http://www.ashp.org/menu/DrugShortages/CurrentShortages/Bulletin.aspx?id=27
Copyright© PerformRx, LLC 2015 All Rights Reserved
236
Source Link: http://www.ashp.org
Methotrexate Injection
May 15, 2015
Reason for the Shortage
 Mylan Institutional cannot provide a reason for the shortage.
 Sandoz discontinued methotrexate 2 mL and 10 mL vials.
 West-Ward Pharmaceuticals’ parent company, Hikma Pharmaceuticals, acquired several
products from Bedford Laboratories in July 2014 including methotrexate injection.
West-Ward is not actively marketing methotrexate injection.
 Teva has methotrexate on short-term back order for standard quality control.
Article Link:
http://www.ashp.org/menu/DrugShortages/CurrentShortages/Bulletin.aspx?id=26
Source Link: http://www.ashp.org
Lorazepam injectable presentations
May 15, 2015
Reason for the Shortage
 Bedford discontinued lorazepam in May, 2011 to concentrate on the manufacturing of
other products.
 West-Ward acquired Baxter’s lorazepam injection products in May, 2011. NDC numbers
for the lorazepam and Ativan products were changed in April, 2012.
 West-Ward had Ativan on back order due to increase surplus of the lorazepam
presentations.
 Hospira states lorazepam vials are on shortage due to increased demand and
manufacturing delays. The 1 mL iSecure syringes were discontinued in September 2011.
 Akorn increased production to help meet demand.
 Amphastar had lorazepam 2 mg/mL vials on shortage due to increased demand.
Article Link:
http://www.ashp.org/menu/DrugShortages/CurrentShortages/Bulletin.aspx?id=747
Source Link: http://www.ashp.org
Etomidate Injection
May 15, 2015
Reason for the Shortage
 American Regent has etomidate injection on shortage due to manufacturing delays.
 Ben Venue stopped production in its plant in Bedford, Ohio and closed in July 2014.
 Hospira has Amidate injection on shortage due to increased demand.
 Par Sterile Products discontinued etomidate in early 2015.
Copyright© PerformRx, LLC 2015 All Rights Reserved
237
Article Link:
http://www.ashp.org/menu/DrugShortages/CurrentShortages/Bulletin.aspx?id=419
Source Link: http://www.ashp.org
Doxorubicin Injection
May 15, 2015
Reason for the Shortage
 West-Ward Pharmacetuicals’ parent company, Hikma Pharmaceuticals, acquired
Adriamycin injection from Bedford in July 2014. West-Ward is not actively marketing
Adriamycin injection at this time.
 Teva has doxorubicin solution for injection available.
 Fresenius Kabi has doxorubicin solution for injection available.
 Caraco has discontinued doxorubicin solution for injection 100 mL vials. The 25 mL vials
are on shortage.
 Pfizer had doxorubicin solution for injection on shortage due to shipping delays.
 Sagent has doxorubicin solution for injection available.
 Mylan cannot provide a reason for the reason for the doxorubicin solution for injection
available.
Article Link:
http://www.ashp.org/menu/DrugShortages/CurrentShortages/Bulletin.aspx?id=464
Source Link: http://www.ashp.org
Dexamethasone Sodium Phosphate
May 15, 2015
Reason for the Shortage
 American Regent has dexamethasone sodium phosphate on shortage due to
manufacturing delays.
 Fresenius Kabi states the dexamethasone sodium phosphate shortage is due to supply
and demand issues.
 West-Ward had dexamethasone sodium phosphate injection on shortage due to
increased demand.
 Mylan Institutional states the shortage is due to increased demand.
Article Link:
http://www.ashp.org/menu/DrugShortages/CurrentShortages/Bulletin.aspx?id=751
Source Link: http://www.ashp.org
Copyright© PerformRx, LLC 2015 All Rights Reserved
238
Carboplatin Solution for Injection
May 15, 2015
Reason for the Shortage
 Bedford discontinued carboplatin in May, 2011 to concentrate on the manufacturing of
other products.
 Fresenius Kabi has carboplatin on shortage due to increased demand for the product.
 Hospira has carboplatin injection available.
 Mylan Institutional cannot provide a reason for the shortage.
 Sagent has carboplatin injection available.
 Sandoz has carboplatin on shortage due to manufacturing delays.
 Teva has carboplatin injection on short-term back order due to standard quality
inspections.
Article Link:
http://www.ashp.org/menu/DrugShortages/CurrentShortages/Bulletin.aspx?id=1005
Source Link: http://www.ashp.org
Calcium Gluconate Injection
May 15, 2015
Reason for the Shortage
 American Regent has calcium gluconate on shortage due to manufacturing delays.
 Fresenius Kabi has replaced calcium gluconate glass vials with plastic vials.
 American Regent has issued a statement that all lots of calcium gluconate may contain
glass particles and filters must be used. Do not use if there are visible glass particles and
filter all other product.
Article Link:
http://www.ashp.org/menu/DrugShortages/CurrentShortages/Bulletin.aspx?id=48
Source Link: http://www.ashp.org
Alcohol Dehydrated Injection (Ethanol)
May 15, 2015
Reason for the Shortage
 American Regent has alcohol dehydrated on back order due to manufacturing delays.
 Hospira and Consolidated Midland discontinued all injectable alcohol dehydrated
products.
Article Link:
http://www.ashp.org/menu/DrugShortages/CurrentShortages/Bulletin.aspx?id=778
Source Link: http://www.ashp.org
Copyright© PerformRx, LLC 2015 All Rights Reserved
239
Acetylcysteine Inhalation Solution
May 15, 2015
Reason for the Shortage
 American Regent has acetylcysteine inhalation on shortage due to manufacturing
delays.
 Roxane Labs discontinued acetylcysteine inhalation solution in April 2014.
 Hospira had acetylcysteine inhalation solution on shortage due to manufacturing delay.
 Fresenius Kabi states the reason for the shortage was increased demand.
Article Link:
http://www.ashp.org/menu/DrugShortages/CurrentShortages/Bulletin.aspx?id=932
Source Link: http://www.ashp.org
Vecuronium Bromide Injection
May 18, 2015
Reason for the Shortage
 Hospira states the shortage is due to manufacturing delays.
 Teva states the shortage is due to manufacturing delays.
 Pfizer sold vecuronium injection to Mylan Institutional in December 2013.
 Ben Venue has stopped production in its plant in Bedford, Ohio and closed in 2014.
 Caraco has vecuronium injection available. NDCs changed in mid-2015.
 Sagent temporarily suspended the manufacture of vecuronium 10 mg and 20 mg vials.
Article Link:
http://www.ashp.org/menu/DrugShortages/CurrentShortages/Bulletin.aspx?id=490
Source Link: http://www.ashp.org
Tolterodine Tartrate Extended Release Capsules
May 18, 2015
Reason for the Shortage
 Mylan discontinued tolterodine extended release 2 mg and 4 mg capsules in 90 count
bottles in April 2014.
 Teva could not provide a reason for the shortage.
Article Link:
http://www.ashp.org/menu/DrugShortages/CurrentShortages/Bulletin.aspx?id=1114
Source Link: http://www.ashp.org
Copyright© PerformRx, LLC 2015 All Rights Reserved
240
Tobramycin Injection
May 18, 2015
Reason for the Shortage
 Teva has tobramycin solution for injection on shortage due to manufacturing delays.
 Hospira has tobramycin on shortage due to manufacturing delays.
 Fresenius Kabi has tobramycin solution for injection on shortage due to increased
demand.
 Mylan Institutional cannot provide a reason for the shortage.
Article Link:
http://www.ashp.org/menu/DrugShortages/CurrentShortages/Bulletin.aspx?id=701
Source Link: http://www.ashp.org
Tacrolimus Capsules
May 18, 2015
Reason for the Shortage
 Novartis discontinued all Hecoria presentations in February 2015.
 Mylan discontinued the 500 count presentations in early 2015.
 Mylan and Kremers Urban could not provide a reason for the shortage.
 Sandoz states the reason for the shortage is manufacturing delay.
Article Link:
http://www.ashp.org/menu/DrugShortages/CurrentShortages/Bulletin.aspx?id=1149
Source Link: http://www.ashp.org
Sterile Water for Injection Large Volume Bags
May 18, 2015
Reason for the Shortage
 Baxter had sterile water for injection on shortage due manufacturing delays.
 BBraun has sterile water for injection on shortage due to increased demand and only
has product available for existing customers.
 Hospira has sterile water for injection available for existing customers.
Article Link:
http://www.ashp.org/menu/DrugShortages/CurrentShortages/Bulletin.aspx?id=1132
Source Link: http://www.ashp.org
Sterile Water Irrigation
May 18, 2015
Reason for the Shortage
 Baxter had sterile water for irrigation on shortage due manufacturing delays.
Copyright© PerformRx, LLC 2015 All Rights Reserved
241


BBraun only has product available for existing customers.
Hospira only has product available for existing customers.
Article Link:
http://www.ashp.org/menu/DrugShortages/CurrentShortages/Bulletin.aspx?id=1120
Source Link: http://www.ashp.org
Sodium Chloride 0.9% Injection Bags
May 18, 2015
Reason for the Shortage
 Baxter has 0.9% sodium chloride on shortage due to increased demand.
 BBraun had 0.9% sodium chloride on allocation due to increased demand.
 Hospira cites increased demand as the reason for the shortage.
 In cooperation with the FDA, Fresenius Kabi is providing 0.9% sodium chloride to the US
market to help alleviate the national shortage. This 0.9% sodium chloride is
manufactured in an FDA-approved facility in Norway by Fresenius Kabi AG. There will be
presentations available with Australian/English label and the package insert is the same
for all imported presentations.
 In cooperation with the FDA, Baxter is providing imported 0.9% sodium chloride to the
US market to help alleviate the national shortage. This 0.9% sodium chloride in Viaflo
containers is manufactured in Spain by Baxter.
Article Link:
http://www.ashp.org/menu/DrugShortages/CurrentShortages/Bulletin.aspx?id=993
Source Link: http://www.ashp.org
Mesna Injection
May 18, 2015
Reason for the Shortage
 Fresenius Kabi had mesna on shortage due to increased demand.
 Mylan cannot give a reason for the shortage of mesna.
 Sagent has mesna on shortage due to manufacturing delays.
 Teva had a shortage of mesna injection due to manufacturing delays.
 West-Ward Pharmaceuticals’ parent company, Hikma Pharmaceuticals, acquired mesna
injection from Bedford in July 2014. West-Ward is not actively marketing mesna
injection at this time.
Article Link:
http://www.ashp.org/menu/DrugShortages/CurrentShortages/Bulletin.aspx?id=1148
Source Link: http://www.ashp.org
Copyright© PerformRx, LLC 2015 All Rights Reserved
242
Leflunomide Tablets
May 18, 2015
Reason for the Shortage
 Apotex states the shortage is due to a delay in obtaining active ingredient.
 Heritage states the shortage is due to a delay in obtaining active ingredient.
 Sanofi could not provide a reason for the shortage.
Article Link:
http://www.ashp.org/menu/DrugShortages/CurrentShortages/Bulletin.aspx?id=711
Source Link: http://www.ashp.org
Hydroxychloroquine Sulfate Tablets
May 18, 2015
Reason for the Shortage
 Concordia acquired Plaquenil tablets from Covis in April 2015.
 Ranbaxy has hydroxychloroquine on shortage due to a regulatory issue.
 Sandoz states the hydroxychloroquine shortage is due to increased demand.
 Zydus could not provide a reason for hydroxychloroquine shortage.
 West-Ward discontinued hydroxychloroquine tablets in September 2014.
Article Link:
http://www.ashp.org/menu/DrugShortages/CurrentShortages/Bulletin.aspx?id=1126
Source Link: http://www.ashp.org
Haloperidol Lactate Injection
May 18, 2015
Reason for the Shortage
 West-Ward Pharmaceuticals’ parent company, Hikma Pharmaceuticals, acquired several
products from Bedford Laboratories in July 2014 including haloperidol lactate injection.
West-Ward is not actively marketing haloperidol lactate at this time.
 Mylan Institutional could not provide a reason for the shortage.
 Sagent could not provide a reason for the shortage.
 Teva has haloperidol lactate on shortage due to manufacturing delays.
 Mylan Institutional acquired haloperidol lactate injection from Pfizer on December 6,
2013.
 Patriot Pharmaceuticals states the reason for the shortage was increased demand.
Article Link:
http://www.ashp.org/menu/DrugShortages/CurrentShortages/Bulletin.aspx?id=527
Source Link: http://www.ashp.org
Copyright© PerformRx, LLC 2015 All Rights Reserved
243
Fomepizole Injection
May 18, 2015
Reason for the Shortage
 Sandoz could not provide a reason for the shortage.1 However, fomepizole injection is
manufactured by Emcure for Sandoz.2 An Emcure manufacturing site was recently
noted to have FDA observations related to GMP and aseptic practices.3
 X-Gen could not provide a reason for the shortage.4
 Mylan Institutional could not provide a reason for the shortage.
Article Link:
http://www.ashp.org/menu/DrugShortages/CurrentShortages/Bulletin.aspx?id=1173
Source Link: http://www.ashp.org
Dipyridamole Injection
May 18, 2015
Reason for the Shortage
 Teva has temporarily discontinued their 2 mL and 10 mL products in order to increase
the package sizes.
Article Link:
http://www.ashp.org/menu/DrugShortages/CurrentShortages/Bulletin.aspx?id=465
Source Link: http://www.ashp.org
Acetaminophen and Codeine Phosphate 300 mg/30 mg Tablets
May 18, 2015
Reason for the Shortage
 Mallinckrodt states the shortage is due a variety of market conditions.
 Amneal, Aurobindo, Mylan, and Teva could not provide a reason for the shortage.
 Qualitest will not provide shortage information for any of their products because they
consider the information to be proprietary.
Article Link:
http://www.ashp.org/menu/DrugShortages/CurrentShortages/Bulletin.aspx?id=1152
Source Link: http://www.ashp.org
Trace Elements Injection
May 19, 2015
Reason for the Shortage
 American Regent has trace element injection on back order due to manufacturing
delays.
 American Regent is the sole supplier of FDA-approved combined trace elements.
Copyright© PerformRx, LLC 2015 All Rights Reserved
244

In cooperation with FDA, Fresenius Kabi USA is providing Addamel N (adult trace
element injection) and Peditrace (pediatric trace element injection) to the US market to
help alleviate the shortage. Addamel N and Peditrace are manufactured in an FDAapproved facility in Norway by Fresenius Kabi AG, the parent company of Fresenius Kabi,
USA.
Article Link:
http://www.ashp.org/menu/DrugShortages/CurrentShortages/Bulletin.aspx?id=785
Source Link: http://www.ashp.org
Nitroglycerin Injection
May 19, 2015
Reason for the Shortage
 American Regent has nitroglycerin vials on back order due to manufacturing delays.
 Hospira discontinued nitroglycerin injection in early 2015.
 Baxter had nitroglycerin premixes on shortage due to a raw material supply issue.
 Baxter had nitroglycerin premixes on shortage due to low supplies.
Article Link:
http://www.ashp.org/menu/DrugShortages/CurrentShortages/Bulletin.aspx?id=786
Source Link: http://www.ashp.org
Milrinone Injection
May 19, 2015
Reason for the Shortage
 Fresenius Kabi states the reason for the shortage is increased demand for the product.
 West-Ward states the shortage is due to manufacturing delays.
 Ben Venue stopped production in its plant in Bedford, Ohio and closed in July 2014.
 Apotex, Bioniche, and Teva discontinued milrinone 1 mg/mL vials.
 Sanofi-Aventis discontinued Primacor injection.
Article Link:
http://www.ashp.org/menu/DrugShortages/CurrentShortages/Bulletin.aspx?id=741
Source Link: http://www.ashp.org
Heparin Premixed Bags
May 19, 2015
Reason for the Shortage
 Baxter and BBraun have product on allocation due to increased demand.
 Hospira states the reason for the shortage is manufacturing delays.
Article Link:
Copyright© PerformRx, LLC 2015 All Rights Reserved
245
http://www.ashp.org/menu/DrugShortages/CurrentShortages/Bulletin.aspx?id=1169
Source Link: http://www.ashp.org
Ammonium Molybdate Injection
May 19, 2015
Reason for the Shortage
 American Regent has ammonium molybdate injection on shortage due to manufacturing
delays.
 American Regent is the sole supplier of ammonium molybdate injection.
Article Link:
http://www.ashp.org/menu/DrugShortages/CurrentShortages/Bulletin.aspx?id=1003
Source Link: http://www.ashp.org
Tamsulosin Hydrochloride Capsules
May 20, 2015
Reason for the Shortage
 Boehringer Ingelheim could not provide a reason for the shortage.
 Actavis and Zydus state the reason for the shortage is increased demand.
 Aurobindo is not marketing the 100 count size.
 Caraco cannot provide a reason for the shortage.
 Teva discontinued tamsulosin 0.4 mg capsules in April 2014.
 Par discontinued tamsulosin 0.4 mg capsules.
 Sandoz has tamsulosin on shortage due to increased demand for the product.
Article Link:
http://www.ashp.org/menu/DrugShortages/CurrentShortages/Bulletin.aspx?id=1112
Source Link: http://www.ashp.org
Levetiracetam Injection
May 20, 2015
Reason for the Shortage
 American Regent states the reason for the shortage is manufacturing delay.
 Caraco cannot provide a reason for the shortage.
 Fresenius states the reason for the shortage is manufacturing delay.
 Hospira states the reason for the shortage is increased demand.
 Sagent states the reason for the shortage is increased demand.
 X-Gen states the reason for the shortage is change in manufacturing site.
Article Link:
http://www.ashp.org/menu/DrugShortages/CurrentShortages/Bulletin.aspx?id=1183
Copyright© PerformRx, LLC 2015 All Rights Reserved
246
Source Link: http://www.ashp.org
Cyanocobalamin Injection
May 20, 2015
Reason for the Shortage
 American Regent has cyanocobalamin injection on shortage due to manufacturing
delays.1
 Fresenius Kabi has cyanocobalamin injection available.
Article Link:
http://www.ashp.org/menu/DrugShortages/CurrentShortages/Bulletin.aspx?id=947
Source Link: http://www.ashp.org
Atorvastatin Tablets
May 20, 2015
Reason for the Shortage
 Ranbaxy discontinued atorvastatin in late-2014.
 Apotex has atorvastatin tablets on allocation due to increased demand.
 Greenstone and Sandoz state the shortage is due to demand exceeding supply.
Article Link:
http://www.ashp.org/menu/DrugShortages/CurrentShortages/Bulletin.aspx?id=989
Source Link: http://www.ashp.org
Amoxicillin 875 mg Tablets
May 20, 2015
Reason for the Shortage
 Aurobindo had amoxicillin on shortage due to manufacturing delays.
 Citron Pharma supplies product to current customers.
 Dr Reddy’s discontinued amoxicillin 875 mg tablets in June 2014.
 Ranbaxy has an FDA import ban on amoxicillin tablets.
 Sandoz cannot provide a reason for the shortage.
 West-Ward has amoxicillin on allocation due to increased demand.
Article Link:
http://www.ashp.org/menu/DrugShortages/CurrentShortages/Bulletin.aspx?id=1141
Source Link: http://www.ashp.org
* Please refer to ASHP website for more information
Copyright© PerformRx, LLC 2015 All Rights Reserved
247
NEW DRUGS COMING TO MARKET
PRODUCT
MFR
ROUTE
LY2963016
Boehringer
Ingelheim/
Eli Lilly
INJ (SC)
Veruprevir
(ABT-450)/
Ombitasvir
(ABT-267)/
Dasabuvir (ABT333)
AbbVie
PO
Sonidegib (LDE225)
Novartis
PO
Evolocumab
(AMG-145)
Amgen
INJ (SC)
MARKET
RELEASE
Type I and II
Novel version of
NDA was filed
diabetes
insulin glargine
12-2013
(biosimilar to
under
Lantus)
505(b)(2)
application;
received
tentative
approval
8/2014;
patent
infringement
lawsuit may
delay launch
beyond
2/2015
Hepatitis C
Hepatitis C virus
All oral triple
NS3/4A protease therapy
inhibitor (given
receives FDA
with ritonavir as
breakthrough
booster)/NS5A
therapy
inhibitor
designation
combination
5/2013; NDA
given with NS5B
filed
polymerase
4/22/2014;
inhibitor
FDA action
dasabuvir
expected
12/2014
Basal cell
Smoothend (Smo) NDA filed
carcinoma
antagonist;
10/2014
Hedgehog (Hh)
signaling pathway
inhibitor
HyperFully human
NDA filed
cholesterolemia antibody that
8/2014; FDA
targets PCSK9;
action date
dosed every 2 or 8/2015
every 4 weeks in
studies
INDICATION
Copyright© PerformRx, LLC 2015 All Rights Reserved
PHARMACOLOGY
248
PRODUCT
MFR
ROUTE
INDICATION
PHARMACOLOGY
Brexpiprazole
Otsuka
PO
Depression,
ADHD,
schizophrenia
D2 dopamine
partial agonist
Aripiprazole
lauroxil
Alkermes
INJ
Schizophrenia
Eluxadoline
(JNJ-27018966)
Janssen/
PO
Irritable bowel
syndrome
Chemotherapy
induced nausea
and vomiting
(prevention)
Duchenne
Muscular
Dystrophy
Long-acting
atypical
antipsychotic
dosed every 2
months
Opioid delta
receptor
antagonists;
opioid mu
receptor agonists
Neurokinin 1
receptor
antagonists
Furiex
Rolapitant
TESARO/
OPKO
Health
PO
Drisapersen
Prosensa
INJ (SC)
Olodaterol/tiotropium
Boehringer
Ingelheim
INH
COPD
Mepolizumab
(Bosatria)
GSK
INJ
(IV,SC)
Asthma, nasal
polyposis
Ivacaftor/lumacaftor
Vertex
PO
Cystic fibrosis
Copyright© PerformRx, LLC 2015 All Rights Reserved
Antisense
nucleotide that
induced specific
skipping of exon
51 during splicing
Fixed-dose
LABA/LAMA
combination with
Respimat inhaler
Humanized
monoclonal
antibody against
human
interleukin-5 (IL5)
Fixed-dose
combination of
lumacaftor and
ivacaftor
MARKET
RELEASE
NDA filed
7/2014; FDA
action date
7/2015
NDA filed
8/2014; FDA
action date
8/2015
NDA filed
9/2014; FDA
priority
review
NDA filed
9/2014
Phase III; FDA
breakthrough
therapy
designation
granted
6/2013;
Rolling NDA
initiated
10/2014
NDA filed
8/2014
BLA filed
11/2014 for
treatment of
asthma
FDA
Breakthrough
Therapy
Designation
249
PRODUCT
MFR
ROUTE
INDICATION
Asfotase
Enobia
Pharma
INJ (SC)
Hypophosphata
sia
Patiromer
Relypsa
PO
Hyperkalemia
CEP-33237
Teva
PO
Moderate to
severe pain
MNK-155
Mallinkrod
t
PO
Moderate to
moderately
severe acute
pain
Copyright© PerformRx, LLC 2015 All Rights Reserved
PHARMACOLOGY
(transmembrane
conductance
regulator
stimulants)
Recombinant
fusion protein
that includes the
catalytic domain
of human tissue
non-specific
alkaline
phosphate
(TNSALP)
Non-absorbed
oral polymeric
compound
known as
patiromer, a
potassium binder
Hydrocodone
extended release
with abuse
deterrent
properties; dosed
once daily
Hydrocodone and
acetaminophen
extended release
MARKET
RELEASE
1/2013; NDA
filed 11/2014
FDA
breakthrough
therapy
designation
5/2013;
rolling BLA
initiated
4/2014
NDA filed
10/2014
Phase III;
Rolling NDA
initiated
10/2014
NDA
submitted
5/2014
250