Alprazolam Tablet, Extended Release
FDA Recall NDC 0228-3083
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 0228-3083). A significant event, classified as Class II, was initiated on Feb 04, 2014 by Actavis Pharma, Inc.. The reported reason for this action was: "Failed Dissolution Specifications: Product did not meet specification requirements for dissolution."
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: Product did not meet specification requirements for dissolution.
Feb 04, 2014
Mar 12, 2014
5,148 bottles
Recall Profile & Regulatory Data
Event ID
67518
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Actavis Elizabeth LLC
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide
Termination Date
Jan 22, 2015
Product Description
Alprazolam Extended-Release Tablets, USP, 3 mg, 60-count tablets per bottle, Rx only, Manufactured by: Actavis Elizabeth LLC, 200 Elmora Avenue, Elizabeth, NJ 07207, NDC 0228-3086-06, UPC 3 0228-3086-06 2.
Batch or Lot Expiration Information
Lot# : 57617531, Exp 03/14
Affected Packages Involved in this Recall
0228-3083-06Product
0228-3084-06Product
0228-3087-06Product
0228-3086-06Product
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.
