Tyenne arthritis medication recalled due to glass particles

Fresenius Kabi has issued a nationwide recall for certain vials of the arthritis medication Tyenne (tocilizumab-aazg) after an internal investigation discovered glass particles in the product. The U.S. Food and Drug Administration (FDA) warned that the presence of glass particles poses severe health risks.

Potential complications include local irritation, pain, or swelling at the infusion site, and inflammation of the veins. More critically, glass particles can cause blockages and clotting in blood vessels, which may lead to permanent organ damage, life-threatening pulmonary embolisms, or death.

The recall specifically affects Tyenne 400 mg/20 mL vials from lot number 16UI07, which have an expiration date of August 2028. These vials were distributed to wholesalers, distributors, and direct customers across the United States between March 3 and March 25. Tyenne is prescribed for adults with moderate to severe rheumatoid arthritis who have not responded sufficiently to other treatments.