Home / Recalls / Caraco Pharmaceutical Laboratories, Ltd. / D-1510-2014

D-1510-2014 Class II Terminated

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

Recall Details

Product Type
Drugs
Report Date
August 13, 2014
Initiation Date
June 26, 2014
Termination Date
March 9, 2015
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
a) 70,152 bottles; b) 43,525 bottles

Product Description

Cephalexin Capsules, USP, 250 mg, packaged in a) 100-count bottles (NDC 62756-293-88) and b) 500-count bottles (NDC 62756-293-13), Rx only, Manufactured by: Sun Pharmaceutical Ind. Ltd., Acme Plaza, Andheri-Kurla Road, Andheri (East), Mumbai-400 059, India.

Reason for Recall

CGMP Deviations: These products are being recalled because they were manufactured with active pharmaceutical ingredients (APIs) that were not manufactured with good manufacturing practices.

Distribution Pattern

Nationwide and Puerto Rico

Code Information

Lot #: a) AGL0098B, AGL0099B, AGL0100B, AGL0101B, Exp 09/14; AGM0073B, AGM0074B, Exp 04/15; AGM0125B, AGM0126B, Exp 07/15; AGM0158B, Exp 09/15; b) AGL0092A, AGL0093A, AGL0094A, AGL0095A, AGL0096A, AGL0097A, AGL0102A, AGL0103A, AGL0104A, AGL0105A, Exp 09/14; AGM0067A, AGM0068A, AGM0069A, Exp 03/15; AGM0070A, AGM0071A, AGM0072A, AGM0085A, AGM0086A, Exp 04/15; AGM0127A, AGM0128A, AGM0129A, AGM0130A, AGM0131A, AGM0132A, Exp 07/15

Other recalls by Caraco Pharmaceutical Laboratories, Ltd.

  • D-1511-2014 Class II — Cephalexin Capsules, USP, 500 mg, packaged in a) 100-count bottles (NDC 62756-29 (June 26, 2014)
  • D-1415-2014 Class II — Venlafaxine Hydrochloride Extended-Release Tablets, 150 mg, Rx only, Packaged in (June 12, 2014)
  • 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-1297-2014 Class III — Children's Cetirizine Hydrochloride Chewable Tablets, 10 mg, 30 count bottle, O (April 9, 2014)
  • D-1284-2014 Class II — Venlafaxine Hydrochloride Extended-Release Tablets, 37.5 mg, packaged in a) 30-c (March 20, 2014)
  • D-1283-2014 Class II — Venlafaxine Hydrochloride Extended-Release Tablets, 150 mg, packaged in a) 30-co (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)
  • D-089-2013 Class II — traMADOL Hydrochloride Tablets, USP 50 mg, 1000-count tablets per bottle, Manufa (November 5, 2012)