Drug product
Clarithromycin Tablets, USP, 500 mg, 20 Tablets, Rx Only, Dist. By: Wockhardt USA LLC, Parsippany, NJ 07054, Repackaged By: Blenheim Pharmacal Inc. North Blenheim, NY 12131, NDC 10544-522-20, MFG: 64679-904-02
D-1110-2015
Product summary
- Event
- Event 71331
- Status
- Terminated
- Classification
- Class II
- Quantity
- 50 bottles
- Official record key
drug-enforcement:D-1110-2015
Official wording
Reason: cGMP Deviations; products being recalled in response to a recall notice from the manufacturer, Wockhardt Limited, following a FDA inspection which noted inadequate investigation of market complaints, resulting in unsuccessful identification of root causes, and the investigation not being expanded to prevent repeat failure
Code information: Lot BP18181301, Exp. Date 02/29/2016
Distribution pattern: Indiana
Derived failure modes
-
Manufacturing or process control
cGMP Deviations