FDA recall D-855-2013

Actavis Inc · Class III · drug

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, UPC 3 67767-142-30 6.

Reason for recall

Failed Dissolution Specifications: Dissolution test results at 8 hour time-point were above approved specification limits.

Distribution

Nationwide and Puerto Rico

Key facts

Status: Terminated
Initiation date: 2013-07-31
Report date: 2013-08-14
Termination date: 2014-05-09
Voluntary/Mandated: Voluntary: Firm initiated
Location: Parsippany, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-855-2013