Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Optiray 320 (ioversol) Injection 68% Recalled by GUERBET LLC Due to Labeling: Not Elsewhere Classified: RFID formatting error which...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact GUERBET LLC directly.
Affected Products
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 Company, LLC., Raleigh, NC 27616; NDC 0019-1323-00.
Quantity: 3860 syringes
Why Was This Recalled?
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.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About GUERBET LLC
GUERBET LLC has 2 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report