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
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