Liebel-Flarsheim recalls OPTIRAY imaging contrast agent after detecting plastic, metal and glass particles
Liebel-Flarsheim Company announced a recall of one lot of its OPTIRAY Imaging Bulk Package, a 350/500 mL vial of ioversol injection used for intra‑arterial and intravenous imaging.
The recall was issued because the product was found to contain particulate matter, including polyethylene, other plastics, stainless steel and glass fragments.
The company warned that injecting such particles could cause local irritation or swelling, and in vulnerable patients could lead to serious events such as vessel blockage or blood clots, although no adverse events have been reported to date.
The affected units are identified by lot number and expiration details, and the recall applies to hospitals, imaging centers and other healthcare facilities in the United States and Mexico.
This writeup was produced by pharmadog from original reporting by fda medwatch.
Original headline: “Liebel-Flarsheim Company, LLC Issues Recall of OPTIRAY Imaging Bulk Package - 350, 500mL, Vial, Nationwide and Mexico Due to Presence of Particulate Matter”
read at fda medwatch ↗
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