Eloxatin — Class II drug recall D-1407-2012
Terminated recall by sanofi-aventis US, Inc., reported 2012-07-11, distributed nationwide. CGMP Deviations: Eloxatin was manufactured by Ben Venue Laboratories, a contract manufacturer, which was recen
| Recall number | D-1407-2012 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | sanofi-aventis US, Inc., Bridgewater, NJ, United States |
| Recall initiated | 2012-02-06 |
| Classified | 2012-07-05 |
| Reported by FDA | 2012-07-11 |
| Terminated | 2013-12-03 |
| Distributed | Nationwide (US) |
| Quantity | 196,355 vials |
| Reason classes | cgmp |
| NDC | 00024-0590-10 |
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
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-1407-2012. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.