Remifentanil HCl active pharmaceutical ingredient (API) for manufacturing, processing or…
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.
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
What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.
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