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.
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.
Lot numbers, UPCs & expiration codes
Lots: L141C, L162A Exp. 06/2021; L146DS, Exp. 05/2021
Where it was sold
Nationwide in the USA
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0137-2020
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Sep 13, 2019
- FDA report date
- Oct 16, 2019
- Quantity
- 3860 syringes
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- GUERBET LLC
Original FDA data
Every field from FDA enforcement report D-0137-2020, exactly as published.
Show all FDA fields
- City
- Princeton
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 83798
- Address
- 821 Alexander Rd, Ste 204
- Address (line 2)
- 120 W 7th St Suite
- Code information
- Lots: L141C, L162A Exp. 06/2021; L146DS, Exp. 05/2021
- Postal code
- 08540-0000
- Report date
- Oct 16, 2019
- Product type
- Drugs
- Recall number
- D-0137-2020
- Classification
- Class II
- Recalling firm
- GUERBET LLC
- Product quantity
- 3860 syringes
- Termination date
- Oct 25, 2021
- 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.
- Voluntary / mandated
- Voluntary: Firm initiated
- 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.
- Distribution pattern
- Nationwide in the USA
- Recall initiation date
- Sep 13, 2019
- Initial firm notification
- Letter
- Center classification date
- Oct 9, 2019