Label Mix-Up Prompts Recall of IV Amiodarone, Tranexamic Acid

Inadvertent administration may result in serious adverse events.

Mylan announced the voluntary recall to the hospital/clinic level of 4 lots of Amiodarone HCl Injection, USP 450mg/9mL and Tranexamic Acid Injection, USP 1000mg/10mL, as the cartons labeled as Tranexamic Acid Injection may potentially contain vials of Amiodarone HCl Injection and vice versa. The individual vials contained within the cartons are accurately labeled. 

The recalled products, Amiodarone HCl Injection, USP 450mg/9mL, NDC Number 67457-0153-09, packaged in cartons of 10 single-dose 9mL vials, and Tranexamic Acid Injection, USP 1000mg/10mL, NDC Number 67457-0197-10, packaged in cartons of 10 single-dose 10mL vials, were distributed nationwide to wholesalers and hospital/clinical pharmacies between April 2020 and July 2020. The recalled lots include the following: 

  • Lot Number 191207; Expiry Date Nov. 2021 
  • Lot Number 191221; Expiry Date Nov. 2021 
  • Lot Number 191223; Expiry Date Nov. 2021
  • Lot Number 200120; Expiry Date Dec. 2021

Amiodarone HCl Injection is 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 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.

According to Mylan, the inadvertent administration or delay of Amiodarone HCl Injection could lead to potentially life-threatening cardiac complications, while inadvertent Tranexamic Acid Injection administration may result in serious adverse events including blood clotting, seizures, hypersensitivity reactions, visual disturbances, and dizziness. Delaying treatment with tranexamic acid may also lead to bleeding events. At this time, the Company has not received any reports of adverse events related to this recall.

Wholesalers and hospital/clinic pharmacies in possession of the recalled product should discontinue use or further distribution. Any adverse events associated with the recall should be reported to the FDA’s MedWatch program.

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For more information regarding this recall contact Mylan Customer Relations by calling (800) 796-9526 or emailing [email protected].


Mylan initiates voluntary nationwide recall of four lots of amiodarone HCl injection, USP and tranexamic acid injection, USP due to carton label mix-up. Accessed August 31, 2020.