Quick answers
- What is Optiray 350?
- Optiray 350 is a brand name of Ioversol, a prescription medicine. The FDA NDC Directory lists 1 Optiray 350 product in 1 strength and form.
- Who makes Optiray 350?
- Liebel-Flarsheim holds the FDA application for Optiray 350 (NDA020923, approved May 29, 1998).
- Is there a generic or store brand of Optiray 350?
- Other products of Ioversol are listed with the FDA, but none in exactly the same strength and form as a Optiray 350 product.
- Has Optiray 350 been recalled?
- FDA enforcement reports list 2 recalls of Optiray 350 products; the newest started July 31, 2026. A recall usually concerns specific lots, not every product.
What Optiray 350 is
Each Optiray 350 product as listed in the FDA NDC Directory, by active ingredient, strength and form, with its official label. “Same medicine, other names” counts the other products with exactly the same active ingredients, strength and form (generic versions, store brands and other brands); inactive ingredients can differ.
Ioversol · prescription medicine
| Strength and form | Product names | Same medicine, other names | Label |
|---|---|---|---|
| ioversol 741 mg/mL injection (intra-arterial, intravenous) | Optiray 350 | None listed | DailyMed |
Its page lists every product and company, the FDA label’s uses and boxed warning, approvals, shortages and recalls: Ioversol →
FDA approval
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
| Application | Holder | First approved | Products |
|---|---|---|---|
| NDA020923 | Liebel-Flarsheim | May 29, 1998 | 1 |
Companies that list Optiray 350
The company named on the package (holder, repackager or distributor), as listed in the FDA NDC Directory, with its number of Optiray 350 products.
- Liebel-Flarsheim Company LLC1 product
Recalls
From FDA enforcement reports, matched by the product’s NDC code or label. A recall usually covers specific lots: check the lot number on your package and ask your pharmacist. Do not stop a medicine on your own.
-
July 31, 2026 · Class I · Ongoing · D-0773-2026
Presence of Particulate Matter: comprising polyethylene and other plastic materials, stainless steel and glass.
Optiray Imaging Bulk Package-350, Ioversol Injection 74%, 350 mg/mL Organically Bound Iodine, 500 mL Multiple-Dose Vial, Rx only, Sterile Solution, Manufactured by: Liebel-Flarsheim Company LLC, Raleigh, NC 27616, Made i — Liebel-Flarsheim Company LLC
-
September 13, 2019 · Class II · Terminated · D-0137-2020
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.
Optiray 320 (ioversol) Injection 68%, 320 mg/mL Organically Bound Iodine, packaged in 1 - 100 mL Ultraject Prefilled Syringe For Power Injection per carton, RFID Technology, Rx Only, Manufactured by: Liebel-Flarshelm Com — GUERBET LLC
Sources
- NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug labeling (SPL, openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
- NADAC (National Average Drug Acquisition Cost) 2026 — Centers for Medicare & Medicaid Services (CMS), data.medicaid.gov, list of November 4, 2026, retrieved November 7, 2026
Which names get a brand page: a name the NDC Directory lists for a medicine, held by one company (the FDA application holder, or the company named on most of its products), that is not just a description, and that is not the only product of its medicine.