Recall record at a glance
| Official record | D-0137-2020 |
|---|---|
| Category | Drug Recalls |
| Classification | Class II |
| FDA record status | Terminated |
| Recalling firm | GUERBET LLC |
| Report date | Oct 16, 2019 |
| Recall initiation date | Sep 13, 2019 |
| Quantity | 3860 syringes |
| Location | Princeton, NJ, United States |
Official 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.
Why the product 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.
Distribution information
Nationwide in the USA
How to read the classification
FDA Class II indicates a situation in which use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or where the probability of serious consequences is remote. The classification shown here comes from the FDA record.
Additional record details
Recall type: Voluntary: Firm initiated. Initial notification: Letter.
What to do next
If you believe you have the recalled product, use the recall number and firm information above to confirm the official notice and follow the instructions issued by the FDA, recalling firm, retailer or product manufacturer. For drugs and medical devices, decisions about treatment or medical care should be discussed with a qualified health professional.
About this record
Recall Lookup USA preserves the most complete source information successfully retrieved. We do not create missing facts or infer affected lots or VINs. The official record may still change, so use the identifier above when verifying current instructions.
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