November 2013 FDA Recall Bupropion Hydrochloride by Actavis Inc
D-1043-2014 - Failed Dissolution Specifications
This Class III drug recall was voluntarily initiated by Actavis Inc on November 15, 2013 for the product Bupropion Hydrochloride. The FDA reported the reason for recall as failed dissolution specifications. The product was distributed Nationwide and the recall is currently terminated.
Recall Number: D-1043-2014
Failed Dissolution Specifications: Failed stability testing for dissolution test at 18 months.
11-15-2013
02-05-2014
139,944 bottles
Recall Profile & Regulatory Data
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Actavis Inc
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide and Puerto Rico
06-16-2015
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
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
