Actavis recalls Fentanyl Transdermal System, 100 mcg/h, each transdermal system contains: 10 mg fentanyl and 0.4 mL alcohol USP, Rx only
Recalled October 3, 2012 · FDA recall D-1693-2012 · Actavis
Hazard
Subpotent; some patches may not contain fentanyl gel · FDA Class II
Units
98,088 cartons (5 pouches per carton)
Sold at
Nationwide
Description
Subpotent; some patches may not contain fentanyl gel
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.
Manufacturer(s)
Actavis
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →