Drug product
Eloxatin (OXALIplatin injection) 5 mg/mL Injection, 50 mg, Rx only, Mfd. for: sanofi aventis US LLC Bridgewater, NJ 08807, NDC 0024-0590-10
D-1407-2012
Product summary
- Event
- Event 62350
- Status
- Terminated
- Classification
- Class II
- Quantity
- 196,355 vials
- Official record key
drug-enforcement:D-1407-2012
Official wording
Reason: 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.
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
Distribution pattern: Nationwide.
Derived failure modes
-
Manufacturing or process control
CGMP Deviations