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U.S. Department of Health and Human Services

Enforcement Report - Week of December 12, 2012

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Product Detail

Product Description traMADOL Hydrochloride Tablets, USP 50 mg, 1000-count tablets per bottle, Manufactured by: Sun Pharmaceuticals Industries, Dadra 396 191, India; Distributed by: Caraco Pharmaceutical Laboratories, Ltd., 1150 Elijah McCoy Drive, Detroit, MI 48202; NDC 57664-377-18.
Recall Number D-089-2013
Classification Class II
Code Info Lot # GKK1373, Exp 09/13
Product Distributed Qty 2,264 bottles
Reason For Recall Adulterated Presence of Foreign Tablets: A customer complaint was received that a bottle of Tramadol HCl Tablets USP 50 mg contained some tablets of Metoprolol Tartrate Tablets USP, 50 mg.

Event Detail

Event Id 63628
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 2012-11-05
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern Nationwide