Radiographic Contrast Agent
Where is Ioversol made?
1 company sell it under their own name. Their labels name 3 factories in the United States and Ireland.
United States 2Ireland 1
Companies and their factories
| Company on the label | Factory | Where | Last FDA inspection |
|---|---|---|---|
| Liebel-Flarsheim Company LLC Optiray 300, Optiray 320, Optiray 350636 mg per 1 mL, 678 mg per 1 mL, 741 mg per 1 mL · NDC 0019-1332, 0019-1323, 0019-1333 | Guerbet Ireland Unlimited CompanyMakes the active ingredient | Dublin, Ireland | Problems found, fixed voluntarilyJun 2023 |
| Liebel-Flarsheim Company LLCMakes it and tests it | Raleigh, NC, United States | Serious problems, FDA actionApr 2025 | |
| SpecGx LLCMakes the active ingredient | St. Louis, MO, United States | Problems found, fixed voluntarilyOct 2025 |
Recalls
- Jul 31, 2026 · Class I · Liebel-Flarsheim Company LLC
Presence of Particulate Matter: comprising polyethylene and other plastic materials, stainless steel and glass. - 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.
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.