Actavis Inc recalls BuPROPion Hydrochloride Extended-Release Tablets (XL), 300 mg, 30-count tablets per bottle, Rx only, Distributed by: Act
Recalled August 14, 2013 · FDA recall D-855-2013 · Actavis
Hazard
Failed Dissolution Specifications: Dissolution test results at 8 hour time-point were above approved specification limits. · FDA Class III
Units
15,132 bottles
Sold at
Nationwide and Puerto Rico
Description
Failed Dissolution Specifications: Dissolution test results at 8 hour time-point were above approved specification limits.
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.
Manufacturer(s)
Actavis Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →