FDA recall D-1693-2012

Actavis · Class II · drug

Product

Fentanyl Transdermal System, 100 mcg/h, each transdermal system contains: 10 mg fentanyl and 0.4 mL alcohol USP, Rx only, supplied in single pouches (NDC 0591-3214-54 (pouch)), 5 pouches per carton (NDC 0591-3214-72 (Carton)), Manufactured by Watson laboratories Inc., Corona, CA, Distributed by: Watson, Pharma Inc.

Reason for recall

Subpotent; some patches may not contain fentanyl gel

Distribution

Nationwide

Key facts

Status: Terminated
Initiation date: 2012-07-11
Report date: 2012-10-03
Termination date: 2013-04-10
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-1693-2012