Drug product
Alprazolam Extended-Release Tablets, USP, 3 mg, 60-count tablets per bottle, Rx only, Manufactured by: Actavis Elizabeth LLC, 200 Elmora Avenue, Elizabeth, NJ 07207, NDC 0228-3086-06, UPC 3 0228-3086-06 2.
D-1091-2014
Product summary
- Event
- Event 67518
- Status
- Terminated
- Classification
- Class II
- Quantity
- 5,148 bottles
- Official record key
drug-enforcement:D-1091-2014
Official wording
Reason: Failed Dissolution Specifications: Product did not meet specification requirements for dissolution.
Code information: Lot #: 57617531, Exp 03/14
Distribution pattern: Nationwide
Derived failure modes
-
Potency or specification failure
Failed Dissolution Specifications