FDA recall D-892-2013

Product

buPROPion Hydrochloride Extended Release Tablets, USP 100 mg, 100 count carton, 10 blister cards of 10 individually blistered and labeled tablets, Rx only, Actavis South Atlantic LLC, Packaged and Distributed by: American Health Packaging, Columbus, OH --- NDC 68084-470-01

Reason for recall

Failed Stability Specifications; out of specification results at the 9 month stability time point for color, dissolution and related compounds.

Distribution

Nationwide

Key facts

Status

Terminated

Initiation date

2013-02-04

Report date

2013-08-21

Termination date

2013-08-28

Voluntary/Mandated

Voluntary: Firm initiated

Location

Columbus, OH, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-892-2013