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Recall Observatory FDA recall evidence

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

May 22, 2015

Class II

Product summary

Firm
Blenheim Pharmacal, Inc.
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

    reason.manufacturing_process_control · v1.0.0

    cGMP Deviations