Drug product
Xanax XR (alprazolam) extended-release tablets, 3 mg, 60-count bottle, Rx only, Distributed by Pharmacia & Upjohn Co, Division of Fizer Inc, NY, NY 10017, NDC 0009-0068-07.
D-0854-2022
Product summary
- Firm
- Viatris Inc
- Event
- Event 90091
- Status
- Terminated
- Classification
- Class II
- Quantity
- 110 bottles
- Official record key
drug-enforcement:D-0854-2022
Official wording
Reason: Failed Dissolution Specifications: low out of specification results for dissolution.
Code information: Lot #: DX7983, exp. date 02/28/2023
Distribution pattern: Product was distributed nationwide in the USA
Derived failure modes
-
Potency or specification failure
out of specification