RecallDepth
Class III Terminated

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

Company
American Health Packaging
Recall Initiated
February 4, 2013
Posted
August 21, 2013
Recall Number
D-892-2013
Voluntary / Mandated
Voluntary: Firm initiated
Quantity
389 cartons
Firm Location
Columbus, OH, United States

Reason for Recall

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

Distribution

Nationwide

Lot / Code Info

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

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