GSK issued a voluntary recall of Clavulin-400
® 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. ® 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: ® 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 ® CLAVULIN is a registered trademark of Glaxo Group Limited, used under license by GlaxoSmithKline Inc. ® 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: __________________________________________________________________ ® CLAVULIN -400 70 mL, DIN# 02238830 Page 2 of 2 ® CLAVULIN is a registered trademark of Glaxo Group Limited, used under license by GlaxoSmithKline Inc.
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