Where it's made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Avantor Performance Materials, LLC | Phillipsburg, NJ, United States | Makes the active ingredient | Problems found, fixed voluntarilyMay 27, 2025 · 7 inspections |
| Liebel-Flarsheim Company LLC | Raleigh, NC, United States | Makes it and tests it | Serious problems, FDA actionApr 8, 2025 · 7 inspections, 1 with FDA action |
Recalls
- Sep 13, 2019 · Class III · Guerbet Llc
Labeling: Not Elsewhere Classified: RFID formatting error which reads product in Ultraject syringe as expired and will not allow injection of product by the Optivantage injector.
Lots: Lots: L159A, Exp. 06/2021; L169A, Exp. 07/2021
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.
Product details
- Generic drug
- Sodium Cation: every company that makes it
- Form
- injection, intravascular
- Strength
- .9 mg per 1 mL
- Approval
- NDA NDA021569
- On the market since
- Sep 1, 2012
- Package NDCs
0019-1188-270019-1188-81- Official label
- DailyMed (National Library of Medicine), updated Dec 20, 2022
Got it by mail or from a pharmacy you don't know? Look the pharmacy up on Who Filled My Rx?