Drug recall D-0137-2020
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.
Reason for recall
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.
Lots and codes
Lots: L141C, L162A Exp. 06/2021; L146DS, Exp. 05/2021
Recall details
- Recalling firm
- GUERBET LLC, Princeton, NJ
- Quantity
- 3860 syringes
- Distribution
- Nationwide in the USA
- Type
- Voluntary: Firm initiated
- Recall initiated
- September 13, 2019
- Terminated
- October 25, 2021
Related products
- Optiray – drug information
- NDC 0019-1332 Optiray 300 · Ioversol 636 mg/mL · Liebel-Flarsheim Company LLC
- NDC 0019-1323 Optiray 320 · Ioversol 678 mg/mL · Liebel-Flarsheim Company LLC
- NDC 0019-1333 Optiray 350 · Ioversol 741 mg/mL · Liebel-Flarsheim Company LLC