Home / Recalls / Caraco Pharmaceutical Laboratories, Ltd. / D-1297-2014

D-1297-2014 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
47,813 bottles

Product Description

Children's Cetirizine Hydrochloride Chewable Tablets, 10 mg, 30 count bottle, OTC, Manufactured by Sun Pharma, Gujarat, India, Distributed Chain Drug Consortium, Boca Raton, FL, NDC 47335-344-83

Reason for Recall

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

Distribution Pattern

Nationwide

Code Information

JKM2070A Exp. 07/14, JKM2071A Exp.10/14, JKM2072A Exp. 01/15, JKM2072B Exp. 01/15, JKM6400A 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-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)
  • D-089-2013 Class II — traMADOL Hydrochloride Tablets, USP 50 mg, 1000-count tablets per bottle, Manufa (November 5, 2012)