Alprazolam Tablet
FDA Recall NDC 0228-2039
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 0228-2039). A significant event, classified as Class II, was initiated on Feb 10, 2014 by Actavis Pharma, Inc.. The reported reason for this action was: "Failed Tablet/Capsule Specifications: Complaints were received for significant tablet erosion for Alprazolam 1 mg."
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 Tablet/Capsule Specifications: Complaints were received for significant tablet erosion for Alprazolam 1 mg.
Feb 10, 2014
Mar 19, 2014
9447 Bottles
Recall Profile & Regulatory Data
Event ID
67519
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Actavis Elizabeth LLC
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide
Termination Date
Aug 25, 2014
Product Description
Alprazolam 1 mg Tablets, USP, 500 count Bottle, Rx Only , C IV, Manufactured by: Actavis Elizabeth LLC 200 Elmora Avenue Elizabeth, NJ 07207 USA, NDC 0228-2031-50
Batch or Lot Expiration Information
Lot# 1826E131, Exp 04/2015
Affected Packages Involved in this Recall
0228-2027-10Product
0228-2027-50Product
0228-2027-96Product
0228-2029-10Product
0228-2029-50Product
0228-2029-96Product
0228-2031-10Product
0228-2031-50Product
0228-2031-96Product
0228-2039-10Product
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.
