FDAFDA · Food and drugs·Recall number D-1408-2012
Eloxatin (OXALIplatin injection) 5 mg/mL injection, 100 mg, Rx only, Mfd. for: sanofi aventis US LLC Bridgewater, NJ 08807, NDC 0024-0591-20
Published July 11, 2012 · Recall initiated: February 6, 2012
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the 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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- sanofi-aventis US, Inc.
- Distributor
- Nationwide.
- Lot
- Lot number and expiration dates Eloxatin¿ (OXALIplatin injection) 100mg vial AD21 02/ 2012 Eloxatin¿ (OXALIplatin injection) 100mg vial AD22 02/ 2012 Eloxatin¿ (OXALIplatin injection) 100mg vial AE24 02/ 2012 Eloxatin¿ (OXALIplatin injection) 100mg vial AE25 02/ 2012 Eloxatin¿ (OXALIplatin injection) 100mg vial AF55 02/ 2012 Eloxatin¿ (OXALIplatin injection) 100mg vial AE26 03/ 2012 Eloxatin¿ (OXALIplatin injection) 100mg vial AF03 03/ 2012 Eloxatin¿ (OXALIplatin injection) 100mg vial AF04 03/ 2012 Eloxatin¿ (OXALIplatin injection) 100mg vial AF21 03/ 2012 Eloxatin¿ (OXALIplatin injection) 100mg vial BL19B 03/ 2012 Eloxatin¿ (OXALIplatin injection) 100mg vial CB11B 04/ 2012 Eloxatin¿ (OXALIplatin injection) 100mg vial CB102B 04/ 2012 Eloxatin¿ (OXALIplatin injection) 100mg vial CB12B 04/ 2012 Eloxatin¿ (OXALIplatin injection) 100mg vial CA01B 04/ 2012 Eloxatin¿ (OXALIplatin injection) 100mg vial BH07 06/ 2012 Eloxatin¿ (OXALIplatin injection) 100mg vial BH08 06/ 2012 Eloxatin¿ (OXALIplatin injection) 100mg vial BH09 06/ 2012 Eloxatin¿ (OXALIplatin injection) 100mg vial CC109B 01/ 2014
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
Sell products like this?
Recalert watches your whole catalog for recalls like this one, automatically.