sanofi-aventis US recalls
FDA enforcement reports naming sanofi-aventis US, Inc. as the recalling firm.
- Recall reports
- 2
- Class I (serious)
- 0
- Most recent report
- Jul 11, 2012
- Jul 11, 2012Eloxatin (OXALIplatin injection) 5 mg/mL Injection, 50 mg, Rx only, MfdDrug · sanofi-aventis US, Inc.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.Class II
- Jul 11, 2012Eloxatin (OXALIplatin injection) 5 mg/mL injection, 100 mg, Rx only, MfdDrug · sanofi-aventis US, Inc.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.Class II