Viatris Inc: Drug Recall

Recall #D-0844-2022 · 04/28/2022

Class II: Risk

Recall Details

Recall Number
D-0844-2022
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
6,789 bottles

Reason for Recall

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

Product Description

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

Distribution Pattern

Product was distributed nationwide in the USA

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.