D-1407-2012 Class II Terminated
FDA drug recall D-1407-2012 was initiated by sanofi-aventis US, Inc. on February 6, 2012 and is designated Class II. Reason for recall: CGMP Deviations: Eloxatin was manufactured by Ben Venue Laboratories, a contract manufacturer, which was recently inspected by the agency and revealed significant issues in Good Manufacturing Practic… The recall status is terminated (terminated December 3, 2013). Affected quantity: 196,355 vials.
Recall Details
- Product Type
- Drugs
- Report Date
- July 11, 2012
- Initiation Date
- February 6, 2012
- Termination Date
- December 3, 2013
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 196,355 vials
Product Description
Eloxatin (OXALIplatin injection) 5 mg/mL Injection, 50 mg, Rx only, Mfd. for: sanofi aventis US LLC Bridgewater, NJ 08807, NDC 0024-0590-10
Reason for Recall
CGMP Deviations: Eloxatin was manufactured by Ben Venue Laboratories, a contract manufacturer, which was recently inspected by the agency and revealed significant issues in Good Manufacturing Practices.
Distribution Pattern
Nationwide.
Code Information
Lot number and expiration dates Eloxatin¿ (OXALIplatin injection) 50mg vial AE41 02/ 2012 Eloxatin¿ (OXALIplatin injection) 50mg vial CA02B 02/ 2012 Eloxatin¿ (OXALIplatin injection) 50mg vial AE27 02/ 2012 Eloxatin¿ (OXALIplatin injection) 50mg vial BL18B 06/ 2012 Eloxatin¿ (OXALIplatin injection) 50mg vial CB13B 06/ 2012 Eloxatin¿ (OXALIplatin injection) 50mg vial CD65B 01/ 2014 Eloxatin¿ (OXALIplatin injection) 50mg vial CE39B 01/ 2014