September 09, 2020
Mylan Institutional is recalling four lots of amiodarone hydrochloride injection and tranexamic acid injection, according to the September 9, 2020, US Food and Drug Administration (FDA) Enforcement Report.
“These batches are being recalled due to the potential for cartons labeled as Tranexamic Acid Injection, USP to contain vials of Amiodarone HCl Injection, USP, and cartons labeled as Amiodarone HCl Injection, USP to contain vials of Tranexamic Acid Injection, USP,” Mylan stated in an August 28, 2020, company announcement. “The individual vials contained within the cartons are accurately labeled as Amiodarone HCl Injection, USP or Tranexamic Acid Injection, USP.”
The recall affects amiodarone hydrochloride injection, 450 mg/9 mL, packaged in cartons of 10 (NDC 67457-153-09) single-dose 9-mL vials (NDC 67457-153-99), and tranexamic acid injection, 1000 mg/10 mL, packaged in cartons of 10 (NDC 67457-197-10) single-dose 10-mL vials (NDC 67457-197-00), from lots 191207, 191221, and 191223 (Exp. 11/21), and 200120 (Exp. 12/21). The injections were distributed to wholesalers and hospital/clinical pharmacies throughout the United States between April 2020 and July 2020.
Mylan voluntarily initiated the recall August 17, 2020. At press time, the FDA had not yet classified the recall, although Mylan warned in its announcement that use of one injection in place of the other presents a risk to patient safety.
Both injections are administered by healthcare professionals in a hospital setting. Amiodarone hydrochloride injection is an antiarrhythmic agent indicated for initiation of treatment and prophylaxis of frequently recurring ventricular fibrillation and hemodynamically unstable ventricular tachycardia in patients refractory to other therapy. Tranexamic acid injection is indicated for short-term use in patients with hemophilia to reduce or prevent hemorrhage and reduce the need for replacement therapy during and following tooth extraction.