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.
What this means for you
Highest-severity recall. Risk of serious injury or death is documented or strongly suspected. 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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