sanofi-aventis US, Inc. recalls Eloxatin (OXALIplatin injection) 5 mg/mL injection, 100 mg, Rx only, Mfd. for: sanofi aventis US LLC Bridgewater, NJ 08
Recalled July 11, 2012 · FDA recall D-1408-2012 · sanofi-aventis US
Hazard
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. · FDA Class II
Units
387,738 vials
Sold at
Nationwide.
Description
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.
Product
Eloxatin (OXALIplatin injection) 5 mg/mL injection, 100 mg, Rx only, Mfd. for: sanofi aventis US LLC Bridgewater, NJ 08807, NDC 0024-0591-20
Manufacturer(s)
sanofi-aventis US, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →