FDA recall D-1043-2014

Actavis Inc · Class III · drug

Product

BuPROPion Hydrochloride Extended-Release Tablet (XL) 150mg, Rx only, a) 30 count bottle(NDC 0591-3331-30), b) 90 count bottle (NDC 0591-3331-19), c) 500 count bottle (NDC 0591-3331-05), Manufactactred By: Watson Laboratories, Inc. Corona, CA 92880

Reason for recall

Failed Dissolution Specifications: Failed stability testing for dissolution test at 18 months.

Distribution

Nationwide and Puerto Rico

Key facts

Status: Terminated
Initiation date: 2013-11-15
Report date: 2014-02-05
Termination date: 2015-06-16
Voluntary/Mandated: Voluntary: Firm initiated
Location: Parsippany, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1043-2014