January 2013 FDA Recall Drug by Actavis Pharmaceuticals
D-175-2013 - Failed Dissolution Specifications; 8-hours for the 18-month stability testing point.
This Class III drug recall was voluntarily initiated by Actavis Pharmaceuticals on January 4, 2013 for the product Drug. The FDA reported the reason for recall as failed dissolution specifications; 8-hours for the 18-month stability testing point.. The product was distributed Nationwide and the recall is currently terminated.
Recall Number: D-175-2013
Failed Dissolution Specifications; 8-hours for the 18-month stability testing point.
01-04-2013
03-06-2013
14,856 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 Pharmaceuticals
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
01-13-2014
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
buPROPion Hydrochloride Extended - Release Tablets (XL) 300 mg, 30 tablet bottles, Rx Only, NDC 67767-142-30 Actavis Distributed by: Actavis South Atlantic LLC Sunrise, FL 33325 Packaged by by: America Health Packaging Columbus, OH 43217
Batch or Lot Expiration Information
Lot# Lot CB1D05A
