Where it's made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Kindeva Drug Delivery L.P. | Northridge, CA, United States | Makes it, tests it, packages it and labels it | Problems found, fixed voluntarilyNov 13, 2025 · 12 inspections |
Recalls
- Jan 31, 2025 · Class I · Alvogen, Inc
Defective delivery system - patches could be multi-stacked, adhered one on top of the other, in a single product pouch.
Lots: Lot #: 108319, Exp: 04/30/2027 - Apr 19, 2019 · Class I · Alvogen, Inc
Product Mix-Up: Customer complaint that their carton labeled as Fentanyl Transdermal Systems, 12 mcg/h contained five patches labeled and containing 50 mcg/h.
Lots: Lot#: 180060, Exp 05/2020; 180073, Exp 06/2020.
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.
Product details
- Generic drug
- Fentanyl: every company that makes it
- Form
- patch, transdermal
- Strength
- 12.5 ug
- Approval
- ANDA ANDA202097
- On the market since
- Nov 4, 2016
- Package NDCs
47781-423-1147781-423-47- Official label
- DailyMed (National Library of Medicine), updated Mar 2, 2026
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