FDA recall D-1345-2015

Product

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

Reason for recall

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.

Distribution

Nationwide and Puerto Rico

Key facts

Status

Terminated

Initiation date

2015-07-17

Report date

2015-08-26

Termination date

2016-03-22

Voluntary/Mandated

Voluntary: Firm initiated

Location

Sharm, United Arab Emirates

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1345-2015