Drug product
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.
D-0137-2020
Product summary
- Firm
- GUERBET LLC
- Event
- Event 83798
- Status
- Terminated
- Classification
- Class II
- Quantity
- 3860 syringes
- Official record key
drug-enforcement:D-0137-2020
Official wording
Reason: 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.
Code information: Lots: L141C, L162A Exp. 06/2021; L146DS, Exp. 05/2021
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Unknown
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.