Alprazolam Tablet, Orally Disintegrating
FDA Recall NDC 0228-4022
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 0228-4022). A significant event, classified as Class II, was initiated on Oct 09, 2013 by Actavis Pharma, Inc.. The reported reason for this action was: "Failed Tablet/Capsule Specifications; partial tablet erosion resulting in tablet weights below specification in some tablets"
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
October 2013 Class II Recall: Failed Tablet/Capsule Specifications; partial tablet erosion resulting in tablet weights below specification in some tablets
Recall Number
Class II Terminated
Failed Tablet/Capsule Specifications; partial tablet erosion resulting in tablet weights below specification in some tablets
Oct 09, 2013
Dec 04, 2013
756 bottles
Recall Profile & Regulatory Data
Event ID
66528
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Actavis Elizabeth LLC
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide
Termination Date
Nov 03, 2014
Product Description
Alprazolam Orally Disintegrating Tablets, USP 2 mg, 100 count bottles, Rx Only, MFG. BY ACTAVIS ELIZABETH LLC., Elizabeth, NJ, NDC 0228-4025-11
Batch or Lot Expiration Information
Lot# 59380831, Exp. May 2014
Affected Packages Involved in this Recall
0228-4019-11Product
0228-4022-11Product
0228-4024-11Product
0228-4025-11Product
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.
