Class II
Terminated
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
- Company
- Blenheim Pharmacal, Inc.
- Recall Initiated
- May 22, 2015
- Posted
- June 3, 2015
- Recall Number
- D-1109-2015
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 166 bottles
- Firm Location
- North Blenheim, NY, United States
Reason for Recall
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
Distribution
Indiana
Lot / Code Info
Lot BP20101301, Exp. Date 02/28/2016
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