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
Recall initiated: 20120711
Status: Terminated
Classification: Class II
Recall type: Voluntary: Firm initiated