Optiray Injection Recalled for Presence of Particulate Matter
Liebel-Flarsheim is recalling 3,486 vials of Optiray Injection due to the presence of particulate matter, including plastic, stainless steel, and glass.
The agency’s classification
FDA (Drugs): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 5/5 (Critical).
Highest-severity recall. The hazard can cause serious injury or death. Stop using the product now and follow the agency's instructions.
Our severity reasoning: The FDA has classified this recall as Class I, which meets the rubric criteria for a Critical severity score.
Plain-English summary
Liebel-Flarsheim Company LLC is recalling 3,486 500 mL vials of Optiray (Ioversol) Injection 74%, 350 mg/mL. The recall is being conducted because the product contains particulate matter comprising polyethylene and other plastic materials, stainless steel, and glass.
The affected product is identified by Lot # 25ZF3670 with an expiration date of May 31, 2027. The vials were distributed nationwide in the US and Mexico. Optiray is a prescription-only sterile solution used as a radiographic contrast agent, administered via intra-arterial or intravenous routes.
Healthcare providers and consumers should stop using the affected product and contact Liebel-Flarsheim Company LLC for further instructions or a return. The FDA has classified this recall as Class I, indicating a reasonable probability that use of the product may cause serious adverse health consequences or death.
The recalled product
- Product
- OPTIRAY (IOVERSOL)
- Brand
- OPTIRAY
- Manufacturer
- Liebel-Flarsheim Company LLC
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- Lot # 25ZF3670
- Exp Date: May 31
- 2027.
UPCs (3)
- 0300191332653
- 0300191323651
- 0300191333650
Distribution
Distributed nationwide across the United States.
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