Home / Recalls / Caraco Pharmaceutical Laboratories, Ltd. / D-089-2013

D-089-2013 Class II Terminated

Recalled by Caraco Pharmaceutical Laboratories, Ltd. — Detroit, MI

Recall Details

Product Type
Drugs
Report Date
December 12, 2012
Initiation Date
November 5, 2012
Termination Date
July 12, 2013
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
2,264 bottles

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.

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.

Distribution Pattern

Nationwide

Code Information

Lot # GKK1373, Exp 09/13

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  • D-1407-2014 Class II — Gemcitabine For Injection USP, 1 g, (lyophilized), For Intravenous Use Only, Ste (April 9, 2014)
  • D-1296-2014 Class III — Cetirizine Hydrochloride Chewable Tablets, 5 mg, 30 count bottle, OTC Manufactur (April 9, 2014)
  • D-1283-2014 Class II — Venlafaxine Hydrochloride Extended-Release Tablets, 150 mg, packaged in a) 30-co (March 20, 2014)
  • D-1284-2014 Class II — Venlafaxine Hydrochloride Extended-Release Tablets, 37.5 mg, packaged in a) 30-c (March 20, 2014)
  • D-1081-2014 Class II — Oxcarbazepine Tablets, 300 mg, 100 tablet bottles, Rx Only. Distributed by: Car (January 29, 2014)
  • D-1089-2014 Class II — Metformin HCl Extended-Release Tablets, USP, 500 mg, Rx only, 500 count bottles (January 28, 2014)