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

FDA recall notice · announced May 11, 2022 · Viatris

Class II FDA/FSIS Class II: use may cause temporary or medically reversible adverse health consequences.

The 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.

Notes

Distribution: Product was distributed nationwide in the USA
Lot/code information: Lot # EH8348, exp. date August 2023
Quantity: 6,789 bottles
Status: Terminated
Products in this recall event:
- alprazolam XR extended-release tablets, 3 mg, 60-count bottle, Rx only, Distributed by: Greenstone LLC, Peapack, NJ 07977, NDC 59762-0068-1. (D-0844-2022)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.