Drug product
Captopril Tablets, USP, 50 mg, 30 Tablets, Rx Only, Dist. By: Wockhardt USA LLC, Parsippany, NJ 07054, Packaged By: Blenheim Pharmacal Inc. North Blenheim, NY 12131, NDC 10544-175-30, MFG: 64679-904-02
D-1109-2015
Product summary
- Event
- Event 71331
- Status
- Terminated
- Classification
- Class II
- Quantity
- 166 bottles
- Official record key
drug-enforcement:D-1109-2015
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 BP20101301, Exp. Date 02/28/2016
Distribution pattern: Indiana
Derived failure modes
-
Manufacturing or process control
cGMP Deviations