Drug product
Rasagiline Tablets 0.5mg, 30-count bottle, Rx only, Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A., NDC 0378-1270-93
D-1171-2023
Product summary
- Event
- Event 92948
- Status
- Terminated
- Classification
- Class II
- Quantity
- 9,890 bottles
- Official record key
drug-enforcement:D-1171-2023
Official wording
Reason: Failed dissolution specifications - results obtained were below spec average.
Code information: Lot #: 3112444, Exp 8/2023
Distribution pattern: USA nationwide
Derived failure modes
-
Potency or specification failure
Failed dissolution specifications