Drug product
Extended Phenytoin Sodium Capsules, USP, 100 mg, 1000 CAPSULES, Rx only, amneal PHARMACEUTICALS label, NDC 65162-212-11 --- Manufactured by: Amneal Pharmaceuticals of NY Hauppauge, NY 11788 Distributed by: Amneal Pharmaceuticals Glasgow, KY 42141
D-66014-001
Product summary
- Event
- Event 66014
- Status
- Terminated
- Classification
- Class II
- Quantity
- 895 - 1000 count bottles
- Official record key
drug-enforcement:D-66014-001
Official wording
Reason: Failed dissolution specifications; 18 month CRT
Code information: Batch/Lot HL50611, exp. 1/2014
Distribution pattern: IL, NH, NJ, NY, OH, RI, TN
Derived failure modes
-
Potency or specification failure
Failed dissolution specifications