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.

Recall Number: D-0245-2025

Firm: Alvogen, Inc

Classification: Class I

Status: Ongoing

Report Date: 20250226

Initiation Date: 20250131

Termination Date:

Defective delivery system - patches could be multi-stacked, adhered one on top of the other, in a single product pouch.

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.