PlainRecalls
FDA Drug Moderate Class II Terminated

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.

Reported: October 3, 2012 Initiated: July 11, 2012 #D-1693-2012

Product Description

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

Details

Recalling Firm
Actavis
Units Affected
98,088 cartons (5 pouches per carton)
Distribution
Nationwide
Location
Salt Lake City, UT

Frequently Asked Questions

What product was recalled?
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.. Recalled by Actavis. Units affected: 98,088 cartons (5 pouches per carton).
Why was this product recalled?
Subpotent; some patches may not contain fentanyl gel
Which agency issued this recall?
This recall was issued by the FDA Drug on October 3, 2012. Severity: Moderate. Recall number: D-1693-2012.