FDA recall D-1446-2016

Product

buPROPion Hydrochloride Extended Release Tablets USP (SR) 150 mg Rx Only 60 tablets Distributed by Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Ind. Ltd., Halol-Baroda Highway, Halol 389-350 Gujarat India ---- NDC 47335-737-86

Reason for recall

Failed Dissolution Specifications

Distribution

Nationwide

Key facts

Status

Terminated

Initiation date

2016-06-27

Report date

2016-07-27

Termination date

2018-03-27

Voluntary/Mandated

Voluntary: Firm initiated

Location

Cranbury, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1446-2016