Drug product
alprazolam XR extended-release tablets, 3 mg, 60-count bottle, Rx only, Distributed by: Greenstone LLC, Peapack, NJ 07977, NDC 59762-0068-1.
D-0844-2022
Product summary
- Firm
- Viatris Inc
- Event
- Event 90045
- Status
- Terminated
- Classification
- Class II
- Quantity
- 6,789 bottles
- Official record key
drug-enforcement:D-0844-2022
Official wording
Reason: Failed Dissolution Specifications: low out-of-specification dissolution test results observed.
Code information: Lot # EH8348, exp. date August 2023
Distribution pattern: Product was distributed nationwide in the USA
Derived failure modes
-
Potency or specification failure
out-of-specification