drugs Class II Updated 2012-07-11

sanofi-aventis US, Inc. recalls Eloxatin (OXALIplatin injection) 5 mg/mL Injection, 50 mg, R

Recalled Product

Eloxatin (OXALIplatin injection) 5 mg/mL Injection, 50 mg, Rx only, Mfd. for: sanofi aventis US LLC Bridgewater, NJ 08807, NDC 0024-0590-10

Hazard / Issue

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.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/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
View official government recall

Looking for safe alternatives?

Browse certified-safe products in this category on Amazon →

Related drugs Recalls

Noven Pharmaceuticals, Inc. recalls Daytrana (methylphenidate) transdermal system patch, Deliver

2012-06-20 · Miscalibrated and/or Defective Delivery System: Out of Specification results for mechanical peel force and/or the z-statistic value which relates to the patient's ability to remove the release liner from the patch adhesive prior to administration.

Ben Venue Laboratories Inc recalls Midazolam HCl Injection, 5 mg/mL, 1 mL single use vials, pac

2012-06-20 · Short Fill: These products are being recalled because there is potential that vials with low fill volume were released into distribution.

Noven Pharmaceuticals, Inc. recalls Daytrana (methylphenidate) transdermal system patch, Deliver

2012-06-20 · Miscalibrated and/or Defective Delivery System: Out of Specification results for mechanical peel force and/or the z-statistic value which relates to the patient's ability to remove the release liner from the patch adhesive prior to administration.

Noven Pharmaceuticals, Inc. recalls Daytrana (methylphenidate) transdermal system patch, Deliver

2012-06-20 · Miscalibrated and/or Defective Delivery System: Out of Specification results for mechanical peel force and/or the z-statistic value which relates to the patient's ability to remove the release liner from the patch adhesive prior to administration.