Drug product
Entacapone Tablets, USP, 200 mg, Rx only, 30 Tablets per unit dose cartons, Distributed by: Major Pharmaceuticals, 17177 N. Laurel Park Dr., Suite 233, Livonia, MI 48152. NDC 0904-6822-04
D-0806-2021
Product summary
- Event
- Event 88638
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1,632 cartons
- Official record key
drug-enforcement:D-0806-2021
Official wording
Reason: Failed Dissolution Specifications
Code information: Lot, expiry: N00187, 05/2022; N00245, 06/2022; N00273, 07/2022; N00355, 11/2022
Distribution pattern: CO, FL, MO, OH
Derived failure modes
-
Potency or specification failure
Failed Dissolution Specifications