Bupropion Hydrochloride Tablet, Film Coated, Extended Release
FDA Recall NDC 0591-3331
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 Bupropion Hydrochloride (NDC 0591-3331). A significant event, classified as Class III, was initiated on Nov 15, 2013 by Actavis Pharma, Inc.. The reported reason for this action was: "Failed Dissolution Specifications: Failed stability testing for dissolution test at 18 months."
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 III Terminated
Failed Dissolution Specifications: Failed stability testing for dissolution test at 18 months.
Nov 15, 2013
Feb 05, 2014
139,944 bottles
Recall Profile & Regulatory Data
Event ID
66961
Classification
Class III
Enforcement Status
Terminated
Recalling Firm
Actavis Inc
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide and Puerto Rico
Termination Date
Jun 16, 2015
Product Description
BuPROPion Hydrochloride Extended-Release Tablet (XL) 150mg, Rx only, a) 30 count bottle(NDC 0591-3331-30), b) 90 count bottle (NDC 0591-3331-19), c) 500 count bottle (NDC 0591-3331-05), Manufactactred By: Watson Laboratories, Inc. Corona, CA 92880
Batch or Lot Expiration Information
Lot# Lots: 524099M, 524100A, 521687A
Affected Packages Involved in this Recall
0591-3331-30Product
0591-3331-19Product
0591-3331-05Product
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.
