American Health Packaging recalls buPROPion Hydrochloride Extended Release Tablets, USP 100 mg, 100 count carton, 10 blister cards of 10 individually blis
Recalled August 21, 2013 · FDA recall D-892-2013 · American Health Packaging
Hazard
Failed Stability Specifications; out of specification results at the 9 month stability time point for color, dissolution and related compounds. · FDA Class III
Units
389 cartons
Sold at
Nationwide
Description
Failed Stability Specifications; out of specification results at the 9 month stability time point for color, dissolution and related compounds.
Product
buPROPion Hydrochloride Extended Release Tablets, USP 100 mg, 100 count carton, 10 blister cards of 10 individually blistered and labeled tablets, Rx only, Actavis South Atlantic LLC, Packaged and Distributed by: American Health Packaging, Columbus, OH --- NDC 68084-470-01
Manufacturer(s)
American Health Packaging
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →