buPROPion Hydrochloride Extended-Release Tablets (XL) 300 mg, 30-count tablets per bottle, Rx only, Distributed by: Actavis South Atlantic LLC, Sunrise, FL 33325; Packaged by: American Health Packaging, Columbus, OH 43217; NDC 67767-142-30.

Recall Number: D-248-2013

Firm: Actavis South Atlantic LLC

Classification: Class III

Status: Terminated

Report Date: 20130424

Initiation Date: 20130322

Termination Date: 20140509

Failed USP Dissolution Test Requirements: Out-of-specification dissolution results at the 8 hour stability testing point.

buPROPion Hydrochloride Extended-Release Tablets (XL) 300 mg, 30-count tablets per bottle, Rx only, Distributed by: Actavis South Atlantic LLC, Sunrise, FL 33325; Packaged by: American Health Packaging, Columbus, OH 43217; NDC 67767-142-30.