Recalls / Class II
Class IID-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.
- Brand name
- Optiray
- Generic name
- Ioversol
- Active ingredient
- Ioversol
- Route
- Intra-arterial, Intravenous
- NDCs
- 0019-1323, 0019-1333, 0019-1332
- FDA application
- NDA019710
- Affected lot / code info
- Lots: L141C, L162A Exp. 06/2021; L146DS, Exp. 05/2021
Why it was 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.
Recalling firm
- Firm
- GUERBET LLC
- Manufacturer
- Liebel-Flarsheim Company LLC
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 821 Alexander Rd, Ste 204, 120 W 7th St Suite, Princeton, New Jersey 08540-0000
Distribution
- Quantity
- 3860 syringes
- Distribution pattern
- Nationwide in the USA
Timeline
- Recall initiated
- 2019-09-13
- FDA classified
- 2019-10-09
- Posted by FDA
- 2019-10-16
- Terminated
- 2021-10-25
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0137-2020. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.