Sun Pharmaceutical Industries, Inc. recalls buPROPion Hydrochloride Extended-release Tablets, USP (SR), 150 mg, a) 60 (NDC 47335-737-86), b) 100 (NDC 47335-737-88)
Recalled February 1, 2017 · FDA recall D-0445-2017 · Sun Pharmaceutical Industries
Hazard
Failed Dissolution Specifications; 18 month stability time point · FDA Class III
Units
a) 141,068 bottles b) 56,834 bottles c) 61,692 bottles
Sold at
Nationwide
Description
Failed Dissolution Specifications; 18 month stability time point
Product
buPROPion Hydrochloride Extended-release Tablets, USP (SR), 150 mg, a) 60 (NDC 47335-737-86), b) 100 (NDC 47335-737-88) and c) 500 (NDC 47335-737-13) 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
Manufacturer(s)
Sun Pharmaceutical Industries, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →