Home / Recalls / Blenheim Pharmacal, Inc. / D-1109-2015

D-1109-2015 Class II Terminated

Recalled by Blenheim Pharmacal, Inc. — North Blenheim, NY

Recall Details

Product Type
Drugs
Report Date
June 3, 2015
Initiation Date
May 22, 2015
Termination Date
January 15, 2016
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
166 bottles

Product Description

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

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 Pattern

Indiana

Code Information

Lot BP20101301, Exp. Date 02/28/2016

Other recalls by Blenheim Pharmacal, Inc.

  • D-1110-2015 Class II — Clarithromycin Tablets, USP, 500 mg, 20 Tablets, Rx Only, Dist. By: Wockhardt US (May 22, 2015)