Drug recall D-0245-2025
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.
Lots and codes
Lot #: 108319, Exp: 04/30/2027
Recall details
- Recalling firm
- Alvogen, Inc, Morristown, NJ
- Quantity
- 112,128 cartons (5 pouches/carton)
- Distribution
- USA Nationwide
- Type
- Voluntary: Firm initiated
- Recall initiated
- January 31, 2025
Related products
- Fentanyl system – drug information
- NDC 47781-424 Fentanyl system · Fentanyl 25 ug/1 · ALVOGEN
- NDC 47781-426 Fentanyl system · Fentanyl 50 ug/1 · ALVOGEN
- NDC 47781-428 Fentanyl system · Fentanyl 100 ug/1 · ALVOGEN
- NDC 47781-427 Fentanyl system · Fentanyl 75 ug/1 · ALVOGEN
- NDC 47781-423 Fentanyl system · Fentanyl 12.5 ug/1 · ALVOGEN