Actavis South Atlantic LLC recalls buPROPion Hydrochloride Extended-Release Tablets (XL) 300 mg, 30-count tablets per bottle, Rx only, Distributed by: Acta
Recalled April 24, 2013 · FDA recall D-248-2013 · Actavis South Atlantic
Hazard
Failed USP Dissolution Test Requirements: Out-of-specification dissolution results at the 8 hour stability testing point. · FDA Class III
Units
555,672 bottles
Sold at
Nationwide
Description
Failed USP Dissolution Test Requirements: Out-of-specification dissolution results at the 8 hour stability testing point.
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.
Manufacturer(s)
Actavis South Atlantic LLC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →