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)…

Recall date

December 20, 2016

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

D-0445-2017

FDA classification

Class III

Brand / firm

Sun Pharmaceutical Industries, Inc.

Sold / distributed

Nationwide

Why it was recalled

Failed Dissolution Specifications; 18 month stability time point

Class III means the product violates regulations but is not likely to cause harm.

What was recalled

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