FDA Announces Recall of OPTIRAY Imaging Agent Due to Particulate Contamination

The FDA has announced a nationwide recall by Liebel-Flarsheim Company, LLC for one lot of OPTIRAY Imaging Bulk Package 350, a radiographic contrast agent. The recall is due to the presence of particulate matter, including plastic, stainless steel, and glass, within the product. Administering injectable products with such contaminants can lead to adverse effects ranging from local irritation and swelling to more severe risks like blood vessel blockage and blood clots, particularly in vulnerable patients. The recall impacts distribution in both the United States and Mexico.