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U.S. Department of Health and Human Services

Enforcement Report - Week of March 5, 2014

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Product Detail

Product Description Metformin HCl Extended-Release Tablets, USP, 500 mg, Rx only, 500 count bottles, Manufactured by: Sun Pharmaceutical Inc. Ltd, Andheri (East) Mumbai-400 059, India, Distributed by: Caraco Pharmaceutical Laboratories, Ltd, Detroit, MI --- NDC 62756-142-02
Recall Number D-1089-2014
Classification Class II
Code Info Batch JKM2433A, Mfg Date 04/2013; Exp 03/2016
Product Distributed Qty 2528 bottles
Reason For Recall Presence of Foreign Tablet; customer complaint of some tablets of Gabapentin found in a bottle of Metformin HCl ER

Event Detail

Event Id 67433
Product Type Drugs
Status Ongoing
Recalling Firm Caraco Pharmaceutical Laboratories, Ltd.
City Detroit
State MI
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2014-01-28
Initial Firm Notification of Consignee or Public E-Mail
Distribution Pattern Nationwide