FDA recall D-1408-2012

sanofi-aventis US, Inc. · Class II · drug

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

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.

Distribution

Nationwide.

Key facts

Status: Terminated
Initiation date: 2012-02-06
Report date: 2012-07-11
Termination date: 2013-12-03
Voluntary/Mandated: Voluntary: Firm initiated
Location: Bridgewater, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1408-2012