Sun Pharmaceutical Industries, Inc. recalls buPROPion Hydrochloride Extended-release Tablets, USP (SR), 200 mg, 60 count bottles, Rx only, Distributed by: Sun Pharm
Recalled February 1, 2017 · FDA recall D-0446-2017 · Sun Pharmaceutical Industries
Hazard
Failed Dissolution Specifications; 18 month stability time point · FDA Class III
Units
11,618 bottles
Sold at
Nationwide
Description
Failed Dissolution Specifications; 18 month stability time point
Product
buPROPion Hydrochloride Extended-release Tablets, USP (SR), 200 mg, 60 count bottles, Rx only, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Ind. Ltd., Halol-Baroda Highway, Halol-389 350, Gujarat, India NDC 47335-0738-86
Manufacturer(s)
Sun Pharmaceutical Industries, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →