FDA recall D-917-2013

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, UPC 3 67767-142-30 6.

Reason for recall

Failed Dissolution Specifications: This recall is an extension of the recall initiated on 07/31/2013 for Bupropion HCl Extended-Release Tablets (XL) 300 mg, because another lot was shown to have similar failing results for dissolution at the 8-hour timepoint.

Distribution

Nationwide and Puerto Rico

Key facts

Status

Terminated

Initiation date

2013-08-21

Report date

2013-09-04

Termination date

2014-04-10

Voluntary/Mandated

Voluntary: Firm initiated

Location

Sunrise, FL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-917-2013