Reported Oct 16, 2019 · Terminated
Optiray 320 (ioversol) Injection 68%, 320 mg/mL Organically Bound Iodine, packaged in 1 - 100 mL Ultraject Prefilled…
Guerbet LLC
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: GUERBET LLC · 821 Alexander Rd, Ste 204 · Princeton, NJ · 08540-0000
Is this the product you have?
- 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 byLiebel-Flarshelm Company, LLC., Raleigh, NC 27616; NDC 0019-1323-00
- Lot codes and dates
- Lots
L141CL162A Exp. 06/2021L146DSExp. 05/2021
- Lots
- Amount recalled
- 3860 syringes
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
- Nationwide
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.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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