Optiray 320 — Class II drug recall D-0137-2020
Terminated recall by GUERBET LLC, reported 2019-10-16, distributed nationwide. Labeling: Not Elsewhere Classified: RFID formatting error which reads product in Ultraject syringe as expired
| Recall number | D-0137-2020 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | GUERBET LLC, Princeton, NJ, United States |
| Recall initiated | 2019-09-13 |
| Classified | 2019-10-09 |
| Reported by FDA | 2019-10-16 |
| Terminated | 2021-10-25 |
| Distributed | Nationwide (US) |
| Quantity | 3,860 syringes |
| Reason classes | labeling |
| NDC | 00019-1323, 00019-1323-00, 00019-1323-02, 00019-1323-04, 00019-1323-06, 00019-1323-11, 00019-1323-16, 00019-1323-21, 00019-1323-27, 00019-1323-52, 00019-1323-55, 00019-1323-70, 00019-1323-73, 00019-1323-75, 00019-1323-77, 00019-1323-78, 00019-1323-81, 00019-1323-83, 00019-1323-85, 00019-1323-87, 00019-1323-90, 00019-1323-91, 00019-1323-95, 00019-1332, 00019-1332-00 and 28 more |
| Lot numbers | L141C, L146DS, L162A |
| Expiration dates | 2021-05, 2021-06 |
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0137-2020. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.