Alprazolam Tablet, Extended Release
FDA Recall NDC 59762-0059
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 1 recorded enforcement report(s) associated with Alprazolam (NDC 59762-0059). A significant event, classified as Class II, was initiated on Apr 28, 2022 by Mylan Pharmaceuticals Inc.. The reported reason for this action was: "Failed Dissolution Specifications: low out-of-specification dissolution test results observed."
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
Reported Recall Events
Class II Terminated
Failed Dissolution Specifications: low out-of-specification dissolution test results observed.
Apr 28, 2022
May 11, 2022
6,789 bottles
Recall Profile & Regulatory Data
Event ID
90045
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Viatris Inc
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Product was distributed nationwide in the USA
Termination Date
Jun 21, 2023
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.
Batch or Lot Expiration Information
Lot# EH8348, exp. date August 2023
Affected Packages Involved in this Recall
59762-0057-1Product
59762-0059-1Product
59762-0066-1Product
59762-0068-1Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
