Fentanyl Transdermal System CII, 25mcg/h, packaged in a pouch, further packaged in 5-count carton...
FDA Recall #D-0245-2025 — Class I — January 31, 2025
Product Description
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.
Recalling Firm
Alvogen, Inc — Morristown, NJ
Classification
Class I — Reasonable probability of serious adverse health consequences or death.
Product Type
Drugs
Product Quantity
112,128 cartons (5 pouches/carton)
Distribution
USA Nationwide
Code Information
Lot #: 108319, Exp: 04/30/2027
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated