Alprazolam Tablet
FDA Recall NDC 59762-3721
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 59762-3721). A significant event, classified as Class II, was initiated on Dec 17, 2014 by Mylan Pharmaceuticals Inc.. The reported reason for this action was: "Subpotent Drug"
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
Subpotent Drug
Dec 17, 2014
Dec 31, 2014
12,310 bottles
Recall Profile & Regulatory Data
Event ID
69985
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Neolpharma, Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide
Termination Date
Apr 26, 2017
Product Description
Alprazolam tablets, USP, CIV, 0.25 mg, Rx Only, a) 500 count bottle, b) 1000 count bottle, Distributed by: Greenstone LLC, Peapack, NJ, 07977, a) NDC 59762-3719-3, b) NDC 59762-3719-4.
Batch or Lot Expiration Information
Lot# : a) C100429, Exp 03/15, b) C120293, Exp 01/17
Affected Packages Involved in this Recall
59762-3719-1Product
59762-3719-3Product
59762-3719-4Product
59762-3720-1Product
59762-3720-3Product
59762-3720-4Product
59762-3721-1Product
59762-3721-3Product
59762-3721-4Product
59762-3722-1Product
59762-3722-3Product
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.
