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
Firm: American Health Packaging
Classification: Class III
Status: Terminated
Report Date: 20130821
Initiation Date: 20130204
Termination Date: 20130828
Reason for Recall
Failed Stability Specifications; out of specification results at the 9 month stability time point for color, dissolution and related compounds.
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