Enforcement Report - Week of July 11, 2012
-
Back to Previous Page
Product Detail
| Product Description | Eloxatin (OXALIplatin injection) 5 mg/mL Injection, 50 mg, Rx only, Mfd. for: sanofi aventis US LLC Bridgewater, NJ 08807, NDC 0024-0590-10 |
|---|---|
| Recall Number | D-1407-2012 |
| Classification | Class II |
| Code Info | 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 |
| Product Distributed Qty | 196,355 vials |
| 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. |
Event Detail
| Event Id | 62350 |
|---|---|
| Product Type | Drugs |
| Status | Ongoing |
| Recalling Firm | sanofi-aventis US, Inc. |
| City | Bridgewater |
| State | NJ | Country | US |
| Voluntary / Mandated | Voluntary: Firm Initiated |
| Recall Initiation Date | 2012-02-06 |
| Initial Firm Notification of Consignee or Public | Letter |
| Distribution Pattern | Nationwide. |
-
