D-0854-2022 Class II Terminated
FDA drug recall D-0854-2022 was initiated by Viatris Inc on Apr 28, 2022 and is designated Class II. Reason for recall: Failed Dissolution Specifications: low out of specification results for dissolution. The recall status is terminated (terminated Jul 13, 2023). Affected quantity: 110 bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- May 18, 2022
- Initiation Date
- Apr 28, 2022
- Termination Date
- Jul 13, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 110 bottles
Product Description
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.
Reason for Recall
Failed Dissolution Specifications: low out of specification results for dissolution.
Distribution Pattern
Product was distributed nationwide in the USA
Code Information
Lot #: DX7983, exp. date 02/28/2023
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0854-2022
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 26, 2026