FDAHealthJanuary 31, 2025
Alvogen, Inc — 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
⚠️ Defective delivery system - patches could be multi-stacked, adhered one on top of the other, in a single product pouch.
Is this relevant to me?
- Geography
- Nationwide
- Source agency
- FDA
- Category
- Health
- Published
- January 31, 2025
USA Nationwide
What's affected?
- 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.
- Brand
- FENTANYL SYSTEM
- Lot code
- 108319
Additional details
Lot #: 108319, Exp: 04/30/2027
What should I do?
Recommended action
Class I recall. Voluntary: Firm initiated Quantity affected: 112,128 cartons (5 pouches/carton).
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