FDA recall D-0844-2022

Viatris Inc · Class II · drug

Product

alprazolam XR extended-release tablets, 3 mg, 60-count bottle, Rx only, Distributed by: Greenstone LLC, Peapack, NJ 07977, NDC 59762-0068-1.

Reason for recall

Failed Dissolution Specifications: low out-of-specification dissolution test results observed.

Distribution

Product was distributed nationwide in the USA

Key facts

Status
Terminated
Initiation date
2022-04-28
Report date
2022-05-11
Termination date
2023-06-21
Voluntary/Mandated
Voluntary: Firm initiated
Location
Canonsburg, PA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0844-2022