Drug product
Fentanyl Citrate Active Pharmaceutical Ingredient, Johnson Matthey Pharmaceutical Materials 2003 Nolte Drive, West Deptford, NJ 08066-1742 (856) 384-7001.
D-1880-2019
Product summary
- Event
- Event 83457
- Status
- Terminated
- Classification
- Class II
- Quantity
- 52882.23 grams
- Official record key
drug-enforcement:D-1880-2019
Official wording
Reason: cGMP Deviations: Potential glass contamination
Code information: Lot #: B0030-180101, B0030-180102, Exp. Feb 2023
Distribution pattern: Nationwide within the United States
Derived failure modes
-
Manufacturing or process control
cGMP Deviations