D-0137-2020 Class II Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- October 16, 2019
- Initiation Date
- September 13, 2019
- Termination Date
- October 25, 2021
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 3860 syringes
Product Description
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.
Distribution Pattern
Nationwide in the USA
Code Information
Lots: L141C, L162A Exp. 06/2021; L146DS, Exp. 05/2021