FDA recall D-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.

Reason for recall

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

Distribution

Product was distributed nationwide in the USA

Key facts

Status

Terminated

Initiation date

2022-04-28

Report date

2022-05-18

Termination date

2023-07-13

Voluntary/Mandated

Voluntary: Firm initiated

Location

Canonsburg, PA, United States

Primary source

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