Class II · Moderate risk
Oxaliplatin Active Pharmaceutical Ingredient
cGMP Deviations: Potential glass contamination
Remifentanil HCl active pharmaceutical ingredient
Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.
Why it was recalled
Failed Impurities/Degradation Specifications: Unknown impurity above specification limits.
Cause type: Impurity / degradation
An impurity or degradation product above its limit - other than nitrosamines. Unexpected substances in a batch can make it unsafe or less effective, even when the active ingredient is present. All impurity / degradation recalls.
What was recalled
Remifentanil HCl active pharmaceutical ingredient (API) for manufacturing, processing or repackaging, 416.95 g glass container, Rx ONLY, Johnson Matthey Pharmaceutical Materials, 2003 Nolte Drive, West Deptford, NJ 08066-1742.
- Recalling firm
- Johnson Matthey Inc.
- Origin
- NJ, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-1252-2019 · FDA notice
Low risk, still worth a check. Class III means the product is unlikely to cause harm but breaks an FDA rule (often labeling). If your lot matches, your pharmacy will normally swap it; there is no need for alarm. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
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 II · Moderate risk
Morphine Sulfate USP Milled
Microbial Contamination of Non-Sterile Products: Bioburden out of specification results for Morphine Sulfate API.
Other impurity / degradation recalls from 2019
All impurity / degradation recalls
Class II · Moderate risk
Sumatriptan Succinate Tablets
Failed Impurities/Degradation Specifications; out-of-specification results obtained for related substance.
Class II · Moderate risk
Sumatriptan Succinate Tablets
Failed Impurities/Degradation Specifications; out-of-specification results obtained for related substance.
Class III · Low risk
Bimatoprost Ophthalmic Solution
Failed Impurities/Degradation Specifications: Out-of-specification result observed in any other individual impurity.
Class II · Moderate risk
Estriol
Failed Impurities/Degradation Specifications: Additional testing found Out of Specification impurity test results.
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