Drug recall
Eloxatin (OXALIplatin injection) 5 mg/mL injection, 100 mg, Rx only, Mfd. for: sanofi aventis US LLC…
FDA recall event 62350 · Class II · sanofi-aventis US, Inc.
Key facts
| Event ID | 62350 |
|---|---|
| Recall numbers | D-1407-2012, D-1408-2012 |
| Recalling firm | sanofi-aventis US, Inc. |
| Product type | Drugs |
| Products | Eloxatin (OXALIplatin injection) 5 mg/mL injection, 100 mg, Rx only, Mfd. for: sanofi aventis US LLC Bridgewater, NJ 08807, NDC 0024-0591-20, Eloxatin (OXALIplatin injection) 5 mg/mL Injection, 50 mg, Rx only, Mfd. for: sanofi aventis US LLC Bridgewater, NJ 08807, NDC 0024-0590-10 |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| 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… |
| Initiation date | Feb 6, 2012 |
| Report date | Jul 11, 2012 |
| Termination date | Dec 3, 2013 |
| City | Bridgewater |
| State | NJ |
| Country | United States |
| FEI number | 2222017 |
At a glance
- 1–9 Products in this recall
- 10–99 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: