Product: Fentanyl Transdermal System CII, 25mcg/h, packaged in a pouch, further packaged in 5-count carton, Rx only, Distributed by: Alvogen, Inc., Pine Brook, NJ 07058, Manufactured by: Kindeva Drug Delivery L/P, Northridge, CA 91324, NDC 47781-424-47.
Reason for recall: Defective delivery system - patches could be multi-stacked, adhered one on top of the other, in a single product pouch.
Recall initiated: 20250131
Status: Ongoing
Classification: Class I
Recall type: Voluntary: Firm initiated