Class II · Moderate risk Terminated
Oxaliplatin Active Pharmaceutical Ingredient
Reason cGMP Deviations: Potential glass contamination
Eloxatin
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
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.
What was recalled
Eloxatin (OXALIplatin injection) 5 mg/mL injection, 100 mg, Rx only, Mfd. for: sanofi aventis US LLC Bridgewater, NJ 08807, NDC 0024-0591-20
- Recalling firm
- sanofi-aventis US, Inc.
- NDC code
- 0024-0591-20
- Origin
- NJ, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-1408-2012
What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.
Other Oxaliplatin recalls
See all
Class II · Moderate risk Terminated
Oxaliplatin 145 Mg /250 Ml D5w Ivpb
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Eloxatin
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.
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