FDA recall D-175-2013

Product

buPROPion Hydrochloride Extended - Release Tablets (XL) 300 mg, 30 tablet bottles, Rx Only, NDC 67767-142-30 Actavis Distributed by: Actavis South Atlantic LLC Sunrise, FL 33325 Packaged by by: America Health Packaging Columbus, OH 43217

Reason for recall

Failed Dissolution Specifications; 8-hours for the 18-month stability testing point.

Distribution

Nationwide

Key facts

Status

Terminated

Initiation date

2013-01-04

Report date

2013-03-06

Termination date

2014-01-13

Voluntary/Mandated

Voluntary: Firm initiated

Location

Morristown, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-175-2013