FDA recall D-0445-2017

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

Reason for recall

Failed Dissolution Specifications; 18 month stability time point

Distribution

Nationwide

Key facts

Status

Terminated

Initiation date

2016-12-20

Report date

2017-02-01

Termination date

2018-07-11

Voluntary/Mandated

Voluntary: Firm initiated

Location

Cranbury, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0445-2017