FDA-Drug2025-02-26Class I
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.
Alvogen, Inc
Hazard
Defective delivery system - patches could be multi-stacked, adhered one on top of the other, in a single product pouch.
Sold states
USA Nationwide
Affected count
112,128 cartons (5 pouches/carton)
Manufactured in
44 Whippany Rd Ste 300, N/A, Morristown, NJ, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0245-2025Don't want to check this manually?
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