Drug Enforcement D-0245-2025

Defective delivery system - patches could be multi-stacked, adhered one on top of the other, in a single product pouch.

Status

Ongoing

Classification

Class I

Report Date

February 26, 2025

Termination Date

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Product Information

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.
Product quantity
112,128 cartons (5 pouches/carton)
Reason for recall
Defective delivery system - patches could be multi-stacked, adhered one on top of the other, in a single product pouch.
Recall initiation reason
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Initial firm notification
Letter
Distribution pattern
USA Nationwide

Location & Firm

Recalling firm
Alvogen, Inc
Address
44 Whippany Rd Ste 300, N/A

United States
Voluntary / Mandated
Voluntary: Firm initiated
Status date
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Codes & Dates

Recall number
D-0245-2025
Event ID
96222
Recall initiation date
January 31, 2025
Center classification date
February 20, 2025
Code info
Lot #: 108319, Exp: 04/30/2027
More code info
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