Viatris Inc: Drug Recall

Recall #D-0854-2022 · 04/28/2022

Class II: Risk

Recall Details

Recall Number: D-0854-2022
Classification: Class II
Product Type: Drug
Recalling Firm: Viatris Inc
Status: Terminated
Date Initiated: 04/28/2022
Location: Canonsburg, PA, United States
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 110 bottles

Reason for Recall

Failed Dissolution Specifications: low out of specification results for dissolution.

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.

Distribution Pattern

Product was distributed nationwide in the USA

Other Recalls by Viatris Inc

Class II: Risk 12/23/2024

Failed Impurities/Degradation Specifications: Out of specification results observed for the impurity compound B during stability testing.
Class II: Risk 12/23/2024

Failed Impurities/Degradation Specifications: Out of specification results observed for the impurity compound B during stability testing.
Class II: Risk 11/18/2024

Superpotent Drug and Subpotent Drug: potency failures obtained
Class II: Risk 11/18/2024

Superpotent Drug and Subpotent Drug: potency failures obtained
Class II: Risk 11/18/2024

Superpotent Drug and Subpotent Drug: potency failures obtained

View all recalls by Viatris Inc →

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.