Liebel-Flarsheim Recalls OPTIRAY Contrast Vials Over Particulate Matter

Liebel-Flarsheim Company, LLC is recalling one lot of OPTIRAY Imaging Bulk Package (IBP) 350, 500mL vials, an injectable radiographic contrast agent, after discovering particulate matter including polyethylene, other plastic materials, stainless steel and glass inside the product. The recall affects hospitals, imaging centers, healthcare facilities, clinics and other end users across the United States and Mexico.

What Products Are Being Recalled?

The recalled product is ‘OPTIRAY Imaging Bulk Package (IBP) 350, 500mL in vial (Ioversol Injection 74% 350 mg iodine/ml)’, a Multiple-Dose Container packaged in cases of six vials. The affected lot carries NDC 0019-1333-65, Lot 25ZF3670, with an expiration date of May 31, 2027. OPTIRAY is used intra-arterially or intravenously as a radiographic contrast agent during medical imaging procedures.

Why Was This Recall Issued?

The recall was triggered by the presence of particulate matter comprising polyethylene and other plastic materials, stainless steel and glass within the vials. Administering an injectable product containing such particulate matter may cause local irritation or swelling at the injection site. In more serious cases, particularly among compromised patients, the contamination could lead to life-threatening complications, including blockage of blood vessels and blood clots. As of the announcement, Liebel-Flarsheim Company, LLC has not received any reports of adverse events connected to this issue.

Who Is Affected?

The affected OPTIRAY 350 IBP 500mL product was distributed to distributors and end users, including hospitals, imaging centers, healthcare facilities and clinics, throughout the United States and Mexico. Patients undergoing imaging procedures involving intra-arterial or intra-venous contrast administration at facilities that received the affected lot may be at risk if the product is used.

What Should You Do?

Distributors, hospitals, healthcare facilities, clinics and other healthcare providers holding the recalled lot should immediately stop use and further distribution of the product, quarantine all affected inventory, and follow the instructions in the customer recall notification to arrange for return of the affected lot to Liebel-Flarsheim Company, LLC. Liebel-Flarsheim is notifying its distributors and customers by email and arranging for return and replacement of all recalled products. Consumers with questions can contact Inmar Inc., the company’s recall processor, at 1-855-670-3976 or by email at rxrecalls@inmar.com. Consumers who have experienced problems potentially related to this product should contact their physician or healthcare provider, and may also report adverse reactions or quality issues to the FDA’s MedWatch Adverse Event Reporting program online, by mail, or by fax to 1-800-FDA-0178.

Official Statement

The company stated that this recall is being conducted with the knowledge of the U.S. Food and Drug Administration. Liebel-Flarsheim Company, LLC confirmed it is notifying distributors and customers by email and arranging for return and replacement of all affected product, and reiterated that no adverse events have been reported to date in connection with this recall.