FDAFDA · Food and drugs·Recall number D-0245-2025
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.
Published February 26, 2025 · Recall initiated: January 31, 2025
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Defective delivery system - patches could be multi-stacked, adhered one on top of the other, in a single product pouch.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Brand
- FENTANYL SYSTEM
- Manufacturer
- Alvogen, Inc
- Distributor
- USA Nationwide
- Lot
- Lot #: 108319, Exp: 04/30/2027
- Risk classification
- Class I
- Area (FDA)
- drug
- Country
- United States
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