RecallDepth
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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