Mylan Recalls Amiodarone HCl and Tranexamic Acid

Mylan has recalled four lots of amiodarone HCl injection, USP 450 mg/9 mL, and tranexamic acid injection, USP 1000 mg/10 mL due to potential labeling mix-ups between the lots. The individual vials contained within the cartons are accurately labeled as amiodarone HCl or tranexamic acid, a recall notice says. XXinseert linkXX)

“If Tranexamic acid is administered to a patient in place of amiodarone or vice versa, it could present a risk to patient safety,” the notice says. “If Amiodarone HCl Injection is inadvertently administered it could result in low blood pressure and irregular heartbeat, including lower than expected heart rate, which could have immediate life-threatening effects on cardiac function.”

Amiodarone is used to treat and prevent certain types of serious, life-threatening ventricular arrhythmias. Tranexamic acid is used to treat heavy bleeding during the menstrual period.