Class II · Moderate risk
Oxaliplatin 145 Mg /250 Ml D5w Ivpb
Lack of Assurance of Sterility
Oxaliplatin Active Pharmaceutical Ingredient
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
cGMP Deviations: Potential glass contamination
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
Oxaliplatin Active Pharmaceutical Ingredient, Johnson Matthey Pharmaceutical Materials 2003 Nolte Drive, West Deptford, NJ 08066-1742 (856) 384-7001, NDC 49821-0075-XX
Affected NDC
49821-0075
Compare with the code on your package — it is the most precise check available.
Drug: Oxaliplatin
- Recalling firm
- Johnson Matthey Inc.
- Origin
- NJ, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-1882-2019 · 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
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.
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 Johnson Matthey Inc.
All 2019 recalls
Class II · Moderate risk
Cisplatin Active Pharmaceutical Ingredient
cGMP Deviations: Potential glass contamination
Class II · Moderate risk
Fentanyl Citrate Active Pharmaceutical Ingredient
cGMP Deviations: Potential glass contamination
Class III · Low risk
Remifentanil HCl active pharmaceutical ingredient
Failed Impurities/Degradation Specifications: Unknown impurity above specification limits.
Class II · Moderate risk
Morphine Sulfate USP Milled
Microbial Contamination of Non-Sterile Products: Bioburden out of specification results for Morphine Sulfate API.
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