Recalls / Class III
Class IIID-1252-2019
Product
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.
- Affected lot / code info
- Lot #: B1319-170101
Why it was recalled
Failed Impurities/Degradation Specifications: Unknown impurity above specification limits.
Recalling firm
- Firm
- Johnson Matthey Inc.
- Notification channel
- Type
- Voluntary: Firm initiated
- Address
- 2003 Nolte Dr, N/A, West Deptford, New Jersey 08066-1727
Distribution
- Quantity
- 416.95 g glass container
- Distribution pattern
- Product was distributed to one manufacturer in Morgantown, WV who may have manufactured the product into finished product and further distribute to the retail level Nationwide in the USA.
Timeline
- Recall initiated
- 2019-04-02
- FDA classified
- 2019-04-30
- Posted by FDA
- 2019-04-24
- Terminated
- 2020-01-10
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1252-2019. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.