D-1252-2019 Class III Terminated
FDA drug recall D-1252-2019 was initiated by Johnson Matthey Inc. on April 2, 2019 and is designated Class III. Reason for recall: Failed Impurities/Degradation Specifications: Unknown impurity above specification limits. The recall status is terminated (terminated January 10, 2020). Affected quantity: 416.95 g glass container.
Recall Details
- Product Type
- Drugs
- Report Date
- April 24, 2019
- Initiation Date
- April 2, 2019
- Termination Date
- January 10, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 416.95 g glass container
Product Description
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.
Reason for Recall
Failed Impurities/Degradation Specifications: Unknown impurity above specification limits.
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.
Code Information
Lot #: B1319-170101