Fentanyl Transdermal System CII recall
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.
Why was Fentanyl Transdermal System CII recalled?
Defective delivery system - patches could be multi-stacked, adhered one on top of the other, in a single product pouch.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot #: 108319, Exp: 04/30/2027
- 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.
- Recalling firm
- Alvogen, Inc
- Quantity
- 112,128 cartons (5 pouches/carton)
- Distribution
- USA Nationwide
- Recall date
- February 26, 2025
- Classification
- Class I
- Status
- Ongoing
- Agency
- FDA (drug)