Product: 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, UPC 3 67767-142-30 6.
Reason for recall: Failed Dissolution Specifications: Dissolution test results at 8 hour time-point were above approved specification limits.
Recall initiated: 20130731
Status: Terminated
Classification: Class III
Recall type: Voluntary: Firm initiated