FDA-Drug2022-05-18Class II

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.

Viatris Inc
Hazard

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

Sold states
Product was distributed nationwide in the USA
Affected count
110 bottles
Manufactured in
1000 Mylan Blvd, N/A, Canonsburg, PA, United States
Products
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.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0854-2022

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