Actavis Inc recalls BuPROPion Hydrochloride Extended-Release Tablets (XL), 300 m
Recalled 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.
Hazard / Issue
Failed Dissolution Specifications: Dissolution test results at 8 hour time-point were above approved specification limits.
Issued by
FDA
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