Where it's made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Hospira, Inc. | Rocky Mount, NC, United States | Makes it, tests it, packages it and labels it | No problems foundFeb 7, 2025 · 11 inspections, 3 with FDA action |
Recalls
- Jul 20, 2020 · Class II · Pfizer Inc.
Lack of Assurance of Sterility; potential loose metal overseal crimp defects.
Lots: Lots: Tray lot: 13405DK Vial lot: 13-405 DK Exp. 1JUL2021, Tray lot: 17096DK Vial lot: 17-096-DK Exp. 1NOV2021 - Dec 3, 2014 · Class II · Hospira Inc.
Lack of Assurance of Sterility; improperly crimped fliptop vials
Lots: Lot 41-099-DK, exp 01MAY2016, NDC 0409-9094-61 - Jun 27, 2014 · Class II · Hospira Inc.
Lack of Assurance of Sterility: Fliptop vial crimps are loose or missing.
Lots: Lot #: 39474DK, Expiry: 03/01/2016.
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
- injection, solution, intramuscular; intravenous
- Strength
- 50 ug per 1 mL
- Approval
- NDA NDA019115
- On the market since
- Nov 15, 2005
- Package NDCs
0409-9093-310409-9093-360409-9093-380409-9093-41- Official label
- DailyMed (National Library of Medicine), updated Aug 24, 2026
Got it by mail or from a pharmacy you don't know? Look the pharmacy up on Who Filled My Rx?