Fentanyl Transdermal System CII, 25mcg/h, packaged in a pouch, further packaged in 5-count carton, Rx only, Distributed by: Alvogen, Inc.,…
Alvogen, Inc · Defective delivery system - patches could be multi-stacked, adhered one on top of the other, in a single product pouch.
- Status
- Ongoing
- City
- Morristown
- State
- NJ
- Country
- United States
- Classification
- Class I
- Product type
- Drugs
- Event ID
- 96222
- Recalling firm
- Alvogen, Inc
- Address 1
- 44 Whippany Rd Ste 300
- Address 2
- N/A
- Postal code
- 07960-4558
- Voluntary mandated
- Voluntary: Firm initiated
- Initial firm notification
- Letter
- Distribution pattern
- USA Nationwide
- Recall number
- D-0245-2025
- 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 date
- 20250131
- Center classification date
- 20250220
- Report date
- 20250226
- Code info
- Lot #: 108319, Exp: 04/30/2027
- 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.
- Harmonized identifiers (openFDA)
- Application number
- ANDA202097
- Brand name
- FENTANYL SYSTEM
- Generic name
- FENTANYL
- Manufacturer name
- ALVOGEN
- Product NDC
- 47781-423, 47781-424, 47781-426, 47781-427, 47781-428
- Product type
- HUMAN PRESCRIPTION DRUG
- Route
- TRANSDERMAL
- Substance name
- FENTANYL
- RxCUI
- 197696, 245134, 245135, 245136, 577057
- SPL ID
- 4b8493ea-0ce4-6949-e063-6294a90a8861
- SPL set ID
- 242759ef-cb6d-4e3e-9f8d-5e31efa1f289
- Package NDC
- 47781-423-11, 47781-423-47, 47781-424-11, 47781-424-47, 47781-426-11, 47781-426-47, 47781-427-11, 47781-427-47, 47781-428-11, 47781-428-47
- Is original packager
- true
- Nui
- N0000175684, N0000175690
- Pharm class moa
- Full Opioid Agonists [MoA]
- Pharm class epc
- Opioid Agonist [EPC]
- UNII
- UF599785JZ