Data Composite

Recall D-0245-2025

US Class I Ongoing · initiated 2025-01-31

Recalling firm

Alvogen, Inc, NJ

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.

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