FDA recall D-248-2013

Product

buPROPion Hydrochloride Extended-Release Tablets (XL) 300 mg, 30-count tablets per bottle, Rx only, Distributed by: Actavis South Atlantic LLC, Sunrise, FL 33325; Packaged by: American Health Packaging, Columbus, OH 43217; NDC 67767-142-30.

Reason for recall

Failed USP Dissolution Test Requirements: Out-of-specification dissolution results at the 8 hour stability testing point.

Distribution

Nationwide

Key facts

Status

Terminated

Initiation date

2013-03-22

Report date

2013-04-24

Termination date

2014-05-09

Voluntary/Mandated

Voluntary: Firm initiated

Location

Sunrise, FL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-248-2013