FDA-Drug2022-05-11Class II

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

Viatris Inc
Hazard

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

Sold states
Product was distributed nationwide in the USA
Affected count
6,789 bottles
Manufactured in
1000 Mylan Blvd, N/A, Canonsburg, PA, United States
Products
alprazolam XR extended-release tablets, 3 mg, 60-count bottle, Rx only, Distributed by: Greenstone LLC, Peapack, NJ 07977, NDC 59762-0068-1.

Official notice

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

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