Class II · Moderate risk
Cisplatin Injection
Failed Impurities/Degradation Specifications.
Cisplatin 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
Cisplatin Active Pharmaceutical Ingredient, Johnson Matthey Pharmaceutical Materials 2003 Nolte Drive, West Deptford, NJ 08066-1742 (856) 384-7001
Drug: Cisplatin
- Recalling firm
- Johnson Matthey Inc.
- Origin
- NJ, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-1881-2019 · 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 Cisplatin recalls
See all
Class II · Moderate risk
Cisplatin 40 MG / 500 ml NS IVPB WITH Mannitol 40 G
Lack of Assurance of Sterility
Class II · Moderate risk
Cisplatin 40 MG / 500 ml NS IVPB WITH Mannitol 40 G
Lack of Assurance of Sterility
Class II · Moderate risk
Cisplatin active pharmaceutical ingredient packaged in varying…
Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05/12 and 02/12/15 are being recalled because they were repackaged in a facility with penicillin products without adequate separation which could introduce the potential for cross contamination with penicillin.
Class II · Moderate risk
Cisplatin 1mg/Ml Injectable 1000 Ml
Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012 because FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared.
Other recalls by Johnson Matthey Inc.
All 2019 recalls
Class II · Moderate risk
Oxaliplatin 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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