Recalling firm
Alvogen, Inc
Product type
Drug
Status
Ongoing
Report date
2025-02-26
Distribution
USA Nationwide
Firm state
NJ
Product quantity
112,128 cartons (5 pouches/carton)
Initiated by
Voluntary: Firm initiated
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.
Code / lot info
Lot #: 108319, Exp: 04/30/2027
Data: U.S. FDA openFDA enforcement API. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification.