Liebel-Flarsheim Company on Aug. 4 issued a nationwide recall of OPTIRAY Imaging Bulk Package, an injectable contrast agent widely used in CT scans. The recall followed the discovery of particulate matter, including polyethylene, stainless steel and glass, in product vials, according to the Food and Drug Administration.
The contaminated product is used in hospital radiology departments across the country, making the recall’s distribution footprint broad and the patient safety implications immediate. Injection of particulate-contaminated solutions can cause vascular injury, organ damage or death.
OPTIRAY is among the most commonly used contrast agents for diagnostic imaging procedures in the United States. Hospitals and imaging centers that have the affected product in their inventories are advised to stop using it immediately.
The recall was posted to the FDA’s enforcement database on Aug. 4. The FDA classifies recalls by severity, with the most serious designations reserved for products that could cause serious adverse health consequences or death.
Injectable contrast agents are administered intravenously to millions of patients annually for CT scans, angiography and other diagnostic imaging procedures. The presence of metal and glass particles in an injectable product represents one of the most serious categories of pharmaceutical contamination.
Patients who have recently undergone imaging procedures using OPTIRAY should contact their health care providers if they experience unusual symptoms, according to the FDA posting.