Product Detail

Product Description 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

Recall Number D-892-2013

Classification Class III

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

Product Distributed Qty 389 cartons

Reason For Recall Failed Stability Specifications; out of specification results
at the 9 month stability time point for color, dissolution and related compounds.

Event Detail

Event Id 65457

Product Type Drugs

Status Ongoing

Recalling Firm

American Health Packaging

City Columbus
State OH
Country US

Voluntary / Mandated Voluntary: Firm Initiated

Recall Initiation Date 2013-02-04

Initial Firm Notification of Consignee or Public Letter

Distribution Pattern Nationwide