Drug product
Alprazolam Orally Disintegrating Tablets, USP 2 mg, 100 count bottles, Rx Only, MFG. BY ACTAVIS ELIZABETH LLC., Elizabeth, NJ, NDC 0228-4025-11
D-018-2014
Product summary
- Event
- Event 66528
- Status
- Terminated
- Classification
- Class II
- Quantity
- 756 bottles
- Official record key
drug-enforcement:D-018-2014
Official wording
Reason: Failed Tablet/Capsule Specifications; partial tablet erosion resulting in tablet weights below specification in some tablets
Code information: Lot # 59380831, Exp. May 2014
Distribution pattern: Nationwide
Derived failure modes
-
Unknown
Failed Tablet/Capsule Specifications; partial tablet erosion resulting in tablet weights below specification in some tablets