Drug Recall: 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
Alvogen, Inc · January 31, 2025
Reason for Recall
Defective delivery system - patches could be multi-stacked, adhered one on top of the other, in a single product pouch.
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.
Distribution
USA Nationwide
States Affected
NATIONWIDE
Quantity Affected
112,128 cartons (5 pouches/carton)
Source: FDA (openFDA Drug Enforcement)
Recall number: D-0245-2025
Status: ongoing
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