FDA recall D-599-2013

Actavis · Class III · drug

Product

Fentanyl Transdermal System, 50 mcg/h, 1 system per pouch (NDC 0591-3212-54), packaged in 5-count systems per box (NDC 0591-3212-72), Rx only, Manufactured by Watson Laboratories, Inc, Corona, CA, 92880 USA; Distributed by: Watson Pharma, Inc.

Reason for recall

Failed Impurities/Degradation Specifications

Distribution

Nationwide

Key facts

Status: Terminated
Initiation date: 2013-06-03
Report date: 2013-06-19
Termination date: 2014-04-09
Voluntary/Mandated: Voluntary: Firm initiated
Location: Salt Lake City, UT, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-599-2013