FDA recall D-0245-2025

Alvogen, Inc · Class I · drug

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.

Distribution

USA Nationwide

Key facts

Status
Ongoing
Initiation date
2025-01-31
Report date
2025-02-26
Voluntary/Mandated
Voluntary: Firm initiated
Location
Morristown, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0245-2025