FDAClass IIMay 11, 2022

alprazolam XR extended-release tablets recall: Failed Dissolution

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

Why was alprazolam XR extended-release tablets recalled?

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

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lot # EH8348, exp. date August 2023

Product
alprazolam XR extended-release tablets, 3 mg, 60-count bottle, Rx only, Distributed by: Greenstone LLC, Peapack, NJ 07977, NDC 59762-0068-1.
Recalling firm
Viatris Inc
Quantity
6,789 bottles
Distribution
Product was distributed nationwide in the USA
Recall date
May 11, 2022
Classification
Class II
Status
Terminated
Agency
FDA (drug)
Open FDA enforcement record Latest recalls