PlainRecalls
FDA Drug Moderate Class II Terminated

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.

Reported: May 18, 2022 Initiated: April 28, 2022 #D-0854-2022

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.

Details

Recalling Firm
Viatris Inc
Units Affected
110 bottles
Distribution
Product was distributed nationwide in the USA
Location
Canonsburg, PA

Frequently Asked Questions

What product was recalled?
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.. Recalled by Viatris Inc. Units affected: 110 bottles.
Why was this product recalled?
Failed Dissolution Specifications: low out of specification results for dissolution.
Which agency issued this recall?
This recall was issued by the FDA Drug on May 18, 2022. Severity: Moderate. Recall number: D-0854-2022.