Sun Pharma Global Fze recalls buPROPion Hydrochloride Extended-¿release Tablets USP (SR), 200 mg, Twice-A-Day, Rx Only, 60 count Bottle, Distributed…

Recall date

July 17, 2015

Source

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

Recall number

D-1345-2015

FDA classification

Class III

Brand / firm

Sun Pharma Global Fze

Sold / distributed

Nationwide and Puerto Rico

Why it was recalled

Failed Dissolution Specification: During analysis of the 18 month long term stability testing, it was noticed that the drug release results at the 4 hour time point are not meeting specifications.

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

What was recalled

buPROPion Hydrochloride Extended-¿release Tablets USP (SR), 200 mg, Twice-A-Day, Rx Only, 60 count Bottle, Distributed by: Sun Pharmaceutical Industries Inc. Cranbury, NJ 08512, Manufactured By: Sun Pharmaceutical Ind. Ltd., Halol Baroda Highway, Halol 389 350, Gujarat, India, NDC 47335-738-86