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.
Recall Number: D-855-2013
Firm: Actavis Inc
Classification: Class III
Status: Terminated
Report Date: 20130814
Initiation Date: 20130731
Termination Date: 20140509
Reason for Recall
Failed Dissolution Specifications: Dissolution test results at 8 hour time-point were above approved specification limits.
Product Description
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.