FDA-Drug2012-10-03Class II

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.

Actavis
Hazard

Subpotent; some patches may not contain fentanyl gel

Sold states
Nationwide
Affected count
98,088 cartons (5 pouches per carton)
Manufactured in
575/577/579 Chipeta Way, N/A, Salt Lake City, UT, United States
Products
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.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1693-2012

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