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.
D-0245-2025
Product summary
- Firm
- Alvogen, Inc
- Event
- Event 96222
- Status
- Ongoing
- Classification
- Class I
- Quantity
- 112,128 cartons (5 pouches/carton)
- Official record key
drug-enforcement:D-0245-2025
Official wording
Reason: Defective delivery system - patches could be multi-stacked, adhered one on top of the other, in a single product pouch.
Code information: Lot #: 108319, Exp: 04/30/2027
Distribution pattern: USA Nationwide
Derived failure modes
-
Unknown
Defective delivery system - patches could be multi-stacked, adhered one on top of the other, in a single product pouch.