GSK issued a voluntary recall of Clavulin-400

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CLAVULIN -400 70 mL, DIN# 02238830
***URGENT***
LEVEL I: PATIENTS, PHARMACY, HOSPITAL, WHOLESALER
ATTENTION:
WHOLESALER, PHARMACY, HOSPITAL and PATIENTS
Date:
April 17, 2015
Manufacturer:
GlaxoSmithKline Inc., Mississauga, Ontario
Product:
CLAVULIN -400 Oral Suspension (400 mg amoxicillin and 57 mg clavulanic acid/5 mL)
70 mL (Lot 710535)
Action Required:
Wholesalers, Pharmacies, Hospitals: Stop distributing and immediately
quarantine the affected lot of CLAVULIN® -400. The details for the specific lot number
implicated are provided in the table on page 2.
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Pharmacies, Hospitals: Notify patients that received the affected lot of CLAVULIN®
-400 and request immediate return to the original place of purchase.
NOTE: Only Lot 710535 of CLAVULIN® -400 is in scope of this recall notice.
Please return all affected stock immediately; refer to the Return Procedure
section.
Reason for Recall:
A single bottle from Lot 710535 was found to contain two glass fragments
approximately 1.5 cm each. As a precautionary measure, all units of Lot 710535,
are being recalled.
Type of Recall,
Health Hazard
Classification:
Type I: “a situation in which there is a reasonable probability that the use of, or
exposure to, a product will cause serious adverse health consequences or
death”
Depth of Recall:
Level 1: Wholesalers, Hospitals, Pharmacies and Patients
Return Procedure:
Further distribution of the listed lot must cease. Please return all affected stock
immediately to Stericycle Inc., indicating the reason for the return as “recalled
product”. Recalled product must be shipped via Purolator Collect. Contact
Purolator at 1-888-744-7123 and quote account # 6815524 and request package
pick up. Please send your returned recalled product to the following address:
GlaxoSmithKline Inc.
C/O Stericycle Inc.
25 Ironside Crescent
Toronto, ON
M1X 1G5
Credit Policy:
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All recalled stock returned within 3 months will receive 100% credit for the quantity
returned based on the original purchase price or the contract price in place at the
time of purchase; no credit will be issued after this date.
CLAVULIN -400 70 mL, DIN# 02238830
Page 1 of 2
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CLAVULIN is a registered trademark of Glaxo Group Limited, used under license by GlaxoSmithKline Inc.
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CLAVULIN -400 70 mL, DIN# 02238830
GlaxoSmithKline remains committed to product quality, integrity, patient safety and satisfaction and are
therefore requesting the return of the product lots listed below.
We appreciate your immediate attention and cooperation, and sincerely regret any inconvenience this
action may cause.
Should you require additional information concerning the return of the affected product, please contact
GSK Customer Service at 1-800-387-7374.
Product: CLAVULIN® -400 (70 mL)
DIN : 02238830
UPC : 7 7093300023 0
Item Code: 40910
Lot Number** First Date of Sales
710535
Last Date of Sales
Expiry Date
April 17, 2015
12 2016
March 10, 2015
Quantity to be
returned *
*indicate zero or the quantity to be returned
Please complete the information below and return a copy by FAX to GSK at 1-800-565-2935. If you are
returning product to Stericycle Inc., please enclose a completed copy of this letter in order for credit to be
issued.
IF YOU ARE NOT RETURNING ANY PRODUCT, PLEASE FAX PAGE 2 BACK, INDICATING ZERO,
FOR REGULATORY COMPLIANCE PURPOSES.
□
□
I do not have any stock of the above
I am returning some stock (add the quantity in the table above)
Name & address of pharmacy / hospital pharmacy: ________________________________________
_______________________________________________________________________________
Wholesaler Name: _______________________________________________________________
Your account number with your wholesaler: ____________________________________________
Signed by: _____________________________________________ Date: ____________________
Name and Title: __________________________________________________________________
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CLAVULIN -400 70 mL, DIN# 02238830
Page 2 of 2
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CLAVULIN is a registered trademark of Glaxo Group Limited, used under license by GlaxoSmithKline Inc.