D-0137-2020 Class II Terminated
FDA drug recall D-0137-2020 was initiated by GUERBET LLC on Sep 13, 2019 and is designated Class II. 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. The recall status is terminated (terminated Oct 25, 2021). Affected quantity: 3860 syringes.
Recall Details
- Product Type
- Drugs
- Report Date
- Oct 16, 2019
- Initiation Date
- Sep 13, 2019
- Termination Date
- Oct 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
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0137-2020
- openFDA file date
- Nov 3, 2026
- Loaded by RegDataLab
- Nov 4, 2026