Where it's made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Guerbet Ireland Unlimited Company | Dublin, Ireland | Makes the active ingredient | Problems found, fixed voluntarilyJun 16, 2023 · 2 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 |
| SpecGx LLC | St. Louis, MO, United States | Makes the active ingredient | Problems found, fixed voluntarilyOct 22, 2025 · 8 inspections |
Recalls
- Jul 31, 2026 · Class I · Liebel-Flarsheim Company LLC
Presence of Particulate Matter: comprising polyethylene and other plastic materials, stainless steel and glass.
Lots: Lot # 25ZF3670, Exp Date: May 31, 2027. - Sep 13, 2019 · Class II · 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: L141C, L162A Exp. 06/2021; L146DS, Exp. 05/2021
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.
Product details
- Generic drug
- Ioversol: every company that makes it
- Form
- injection, intra-arterial; intravenous
- Strength
- 636 mg per 1 mL
- Approval
- NDA NDA020923
- On the market since
- Oct 17, 2011
- Package NDCs
0019-1332-61- Official label
- DailyMed (National Library of Medicine), updated Dec 29, 2025
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