FDA Drug recall D-1407-2012
Eloxatin (OXALIplatin injection) 5 mg/mL Injection, 50 mg, Rx only, Mfd. for: sanofi aventis US LLC Bridgewater, NJ 08807, NDC 0024-0590-10
- FDA Drug
- Class II
- terminated
- Published 2012-07-11
On 2012-07-11 the FDA classified a Class II recall of Eloxatin (OXALIplatin injection) 5 mg/mL Injection, 50 mg, Rx only, Mfd. for: sanofi aventis US LLC Bridgewater, NJ 08807, NDC 0024-0590-10 by Sanofi Aventis Us, citing 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 M….
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-1407-2012 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2012-02-06 |
| Published | 2012-07-11 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Sanofi Aventis Us |
| Distribution | US |
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
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.
Identifiers
| code_info | Lot number and expiration dates Eloxatin¿ (OXALIplatin injection) 50mg vial AE41 02/ 2012 Eloxatin¿ (OXALIplatin i…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 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:51 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1407-2012%22
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