Recalls / Class II
Class IID-0854-2022
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.
- Affected lot / code info
- Lot #: DX7983, exp. date 02/28/2023
Why it was recalled
Failed Dissolution Specifications: low out of specification results for dissolution.
Recalling firm
- Firm
- Viatris Inc
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 1000 Mylan Blvd, N/A, Canonsburg, Pennsylvania 15317-5853
Distribution
- Quantity
- 110 bottles
- Distribution pattern
- Product was distributed nationwide in the USA
Timeline
- Recall initiated
- 2022-04-28
- FDA classified
- 2022-05-06
- Posted by FDA
- 2022-05-18
- Terminated
- 2023-07-13
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0854-2022. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.