Drug product
Phenobarbital Tablets, USP 60mg 100=count bottles, Rx Only, Mfd. by: West-Ward Pharmaceutical Corp. Eatontown, NJ 07724, NDC 0143-1455-01
D-1045-2017
Product summary
- Event
- Event 75261
- Status
- Terminated
- Classification
- Class II
- Quantity
- N/A
- Official record key
drug-enforcement:D-1045-2017
Official wording
Reason: Failed Dissolution Specifications: Phenobarbital Tablets have an out of specification for dissolution at the 12 month stability time point
Code information: Lot #: 71294A, Exp. 5/2017
Distribution pattern: Nationwide
Derived failure modes
-
Potency or specification failure
out of specification