Actavis Inc recalls BuPROPion Hydrochloride Extended-Release Tablet (XL) 150mg, Rx only, a) 30 count bottle(NDC 0591-3331-30), b) 90 count b
Recalled February 5, 2014 · FDA recall D-1043-2014 · Actavis
Hazard
Failed Dissolution Specifications: Failed stability testing for dissolution test at 18 months. · FDA Class III
Units
139,944 bottles
Sold at
Nationwide and Puerto Rico
Description
Failed Dissolution Specifications: Failed stability testing for dissolution test at 18 months.
Product
BuPROPion Hydrochloride Extended-Release Tablet (XL) 150mg, Rx only, a) 30 count bottle(NDC 0591-3331-30), b) 90 count bottle (NDC 0591-3331-19), c) 500 count bottle (NDC 0591-3331-05), Manufactactred By: Watson Laboratories, Inc. Corona, CA 92880
Manufacturer(s)
Actavis Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →