February 2013 FDA Recall Drug by American Health Packaging
D-892-2013 - Failed Stability Specifications; out of specification results at the 9 month stability time point for color, dissolution and related compounds.

This Class III drug recall was voluntarily initiated by American Health Packaging on February 4, 2013 for the product Drug. The FDA reported the reason for recall as failed stability specifications; out of specification results at the 9 month stability time point for color, dissolution and related compounds.. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-892-2013

Reason for Recall
Failed Stability Specifications; out of specification results at the 9 month stability time point for color, dissolution and related compounds.
Initiated
02-04-2013
Reported
08-21-2013
Quantity
389 cartons

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
65457
Classification About Classification
Relative degree of health hazard assigned by FDA.
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.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
American Health Packaging
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
08-28-2013
Product Description About Product Description
Full technical description of the product.
buPROPion Hydrochloride Extended Release Tablets, USP 100 mg, 100 count carton, 10 blister cards of 10 individually blistered and labeled tablets, Rx only, Actavis South Atlantic LLC, Packaged and Distributed by: American Health Packaging, Columbus, OH --- NDC 68084-470-01

Batch or Lot Expiration Information

Lot# The following codes are affects by the recall:
Lot# 114500, Exipration Date 08/2013, repackaging date 12/04/2011.