PlainRecalls
FDA Drug Moderate Class II Terminated

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

Reported: May 11, 2022 Initiated: April 28, 2022 #D-0844-2022

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.

Reason for Recall

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

Details

Recalling Firm
Viatris Inc
Units Affected
6,789 bottles
Distribution
Product was distributed nationwide in the USA
Location
Canonsburg, PA

Frequently Asked Questions

What product was recalled?
alprazolam XR extended-release tablets, 3 mg, 60-count bottle, Rx only, Distributed by: Greenstone LLC, Peapack, NJ 07977, NDC 59762-0068-1.. Recalled by Viatris Inc. Units affected: 6,789 bottles.
Why was this product recalled?
Failed Dissolution Specifications: low out-of-specification dissolution test results observed.
Which agency issued this recall?
This recall was issued by the FDA Drug on May 11, 2022. Severity: Moderate. Recall number: D-0844-2022.