Home / Recalls / Caraco Pharmaceutical Laboratories, Ltd. / D-1296-2014

D-1296-2014 Class III Terminated

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

Recall Details

Product Type
Drugs
Report Date
May 7, 2014
Initiation Date
April 9, 2014
Termination Date
October 7, 2014
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
128,363 bottles

Product Description

Cetirizine Hydrochloride Chewable Tablets, 5 mg, 30 count bottle, OTC Manufactured by Sun Pharma, Gujarat, India, NDC 47335-343-83

Reason for Recall

Failed Impurities/Degradation Specifications: out of specification results for impurities/degradation testing for N-Oxide

Distribution Pattern

Nationwide

Code Information

JKM2067A Exp. 07/14, JKM2068A Exp.10/14, JKM2069A Exp. 01/15, JKM6399A Exp. 04/15

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-1510-2014 Class II — Cephalexin Capsules, USP, 250 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-1297-2014 Class III — Children's Cetirizine Hydrochloride Chewable Tablets, 10 mg, 30 count bottle, O (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)
  • D-089-2013 Class II — traMADOL Hydrochloride Tablets, USP 50 mg, 1000-count tablets per bottle, Manufa (November 5, 2012)