Class II · Moderate risk
Oxaliplatin Active Pharmaceutical Ingredient
cGMP Deviations: Potential glass contamination
Eloxatin (OXALIplatin injection)
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
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.
Cause type: cGMP deviation
Departures from current Good Manufacturing Practice found in production or during FDA inspection. A broad quality-system cause: the batch was made under conditions that fall short of FDA manufacturing standards. All cgmp deviation recalls.
What was recalled
Eloxatin (OXALIplatin injection) 5 mg/mL injection, 100 mg, Rx only, Mfd. for: sanofi aventis US LLC Bridgewater, NJ 08807, NDC 0024-0591-20
Affected NDC
0024-0591-20
Compare with the code on your package — it is the most precise check available.
Drug: Oxaliplatin
- Recalling firm
- sanofi-aventis US, Inc.
- NDC code
- 0024-0591-20
- Origin
- NJ, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-1408-2012 · FDA notice
Check, then ask. Class II means harm is possible but usually temporary or reversible. Find the lot number on your package; if it matches, ask your pharmacist about a replacement. Do not simply stop a prescribed medication on your own - the gap can be riskier than the recall. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
Other Oxaliplatin recalls
See all
Class II · Moderate risk
Oxaliplatin 145 Mg /250 Ml D5w Ivpb
Lack of Assurance of Sterility
Class II · Moderate risk
Eloxatin (OXALIplatin injection)
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.
Other recalls by sanofi-aventis US, Inc.
All 2012 recalls
Class II · Moderate risk
Eloxatin (OXALIplatin injection)
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.
Other cgmp deviation recalls from 2012
All cgmp deviation recalls
Class II · Moderate risk
ABILIFY (aripiprazole)
CGMP Deviations: A drum of Abilify 30 mg Tablets rejected during the compression stage was not segregated from the other portion of the lot and was inadvertently shipped, packaged and distributed.
Class II · Moderate risk
All Non-Sterile Products manufactured by Ameridose LLC
GMP deficiencies
Class II · Moderate risk
All Non Sterile Products manufactured by NECC
GMP Deviations
Class III · Low risk
Lemon Hand Sanitizing Wipes
CGMP Deviations: The products were manufactured with raw material which contain unknown particles believed to be water and dirt.
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