The Food and Drug Administration (FDA) is reporting on Mylan N.V.’s voluntary nationwide recall of specific lots of amiodarone HCl injection and tranexamic acid injection due to the potential of the cartons being mislabeled.
This recall includes 4 lots of amiodarone HCl injection, USP 450 mg/9 mL, packaged in cartons of 10 single-dose 9 mL vials and tranexamic acid injection, USP 1000 mg/10 mL, packaged in cartons of 10 single-dose 10 mL vials. Amiodarone HCl injection, USP and tranexamic acid injection, USP are used to treat different conditions. Amiodarone is indicated for treatment and prophylaxis of frequently recurring ventricular fibrillation and hemodynamically unstable ventricular tachycardia in patients refractory to other therapy. Tranexamic acid is indicated in patients with hemophilia for short term use to reduce or prevent hemorrhage and reduce the need for replacement therapy during and following tooth extraction. If tranexamic acid is administered to a patient in place of amiodarone or vice versa, it could present a risk to patient safety. To date, Mylan has not received any reports of adverse events related to this recall.
Food and Drug Administration (FDA). Mylan Initiates Voluntary Nationwide Recall of Four Lots of Amiodarone HCl Injection, USP and Tranexamic Acid Injection, USP Due to Carton Label Mix-Up [news release]. August 31, 2020. Available at: click here. Accessed September 2, 2020.