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.
Reported: February 26, 2025 Initiated: January 31, 2025 #D-0245-2025
Product Description
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.
Details
- Recalling Firm
- Alvogen, Inc
- Units Affected
- 112,128 cartons (5 pouches/carton)
- Distribution
- USA Nationwide
- Location
- Morristown, NJ
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Alvogen, Inc. Units affected: 112,128 cartons (5 pouches/carton).
Why was this product recalled? ▼
Defective delivery system - patches could be multi-stacked, adhered one on top of the other, in a single product pouch.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on February 26, 2025. Severity: Critical. Recall number: D-0245-2025.
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