Class I
Ongoing
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.
- Company
- Alvogen, Inc
- Recall Initiated
- January 31, 2025
- Posted
- February 26, 2025
- Recall Number
- D-0245-2025
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 112,128 cartons (5 pouches/carton)
- Firm Location
- Morristown, NJ, United States
Reason for Recall
Defective delivery system - patches could be multi-stacked, adhered one on top of the other, in a single product pouch.
Distribution
USA Nationwide
Lot / Code Info
Lot #: 108319, Exp: 04/30/2027
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