Drug product
Extended Phenytoin Sodium Capsules, USP, 100 mg, 100-count bottle, Distributed by Amneal Pharmaceuticals LLC Bridgewater, NJ, 08807, NDC# 65162-212-10
D-0090-2024
Product summary
- Event
- Event 93292
- Status
- Terminated
- Classification
- Class II
- Quantity
- 9,263 100-count bottles
- Official record key
drug-enforcement:D-0090-2024
Official wording
Reason: Failed Dissolution Specifications
Code information: Lot # HM03221A, Exp. date 12/31/2023
Distribution pattern: Nationwide in the USA and Puerto Rico
Derived failure modes
-
Potency or specification failure
Failed Dissolution Specifications