Drug product
Extended Phenytoin Sodium Capsules, USP, 100 mg, Rx Only, 100 capsules per bottle, Distributed by: Amneal Pharmaceuticals LLC., Bridgewater, NJ 08807, NDC 65162-212-10.
D-0876-2023
Product summary
- Event
- Event 92368
- Status
- Terminated
- Classification
- Class II
- Quantity
- 9,056 bottles
- Official record key
drug-enforcement:D-0876-2023
Official wording
Reason: Failed Dissolution Specifications: Out-of-specification results for dissolution (above specification)
Code information: Lot # HL00721A, Exp. 12/2023
Distribution pattern: LA, PA and OH.
Derived failure modes
-
Potency or specification failure
Out-of-specification