Home / Recalls / Caraco Pharmaceutical Laboratories, Ltd. / D-1407-2014

D-1407-2014 Class II Terminated

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

Recall Details

Product Type
Drugs
Report Date
July 2, 2014
Initiation Date
April 9, 2014
Termination Date
September 29, 2014
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
200 vials

Product Description

Gemcitabine For Injection USP, 1 g, (lyophilized), For Intravenous Use Only, Sterile Single Use Vial, Rx only, Manufactured by: Sun Pharmaceutical Ind. Ltd, Gujarat, India, NDC 47335-154-40

Reason for Recall

Lack of Assurance of Sterility: A particle excursion for a different batch of the same product may lead to a lack of sterility assurance.

Distribution Pattern

OH

Code Information

JKM7188A

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-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-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)