FDASeptember 13, 2019drug
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.
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
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.
What to do
FDA enforcement status: Terminated
Brands named
guerbet
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
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