drugs Class III Updated 2013-08-21

American Health Packaging recalls buPROPion Hydrochloride Extended Release Tablets, USP 100 mg

Recalled 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


Hazard / Issue

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

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: The following codes are affects by the recall: Lot #114500, Exipration Date 08/2013, repackaging date 12/04/2011.
View official government recall

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