Drug Safety Alerts

Amiodarone Hydrochloride Injection and Tranexamic Acid Injection Class I Recalls

9/12/2020

On September 12, 2020, the United States Food and Drug Administration published a notice regarding Class I recalls of Amiodarone HCl Injection and Tranexamic Acid Injection manufactured by Mylan. These recalls were issued 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. The individual vials contained within the cartons are accurately labeled as Amiodarone HCl Injection USP or Tranexamic Acid Injection USP. Both of these medications are administered in a hospital setting only by trained healthcare professionals.

This could be a health hazard or safety risk to patients using product affected by this recall.

A list of the affected products and lot numbers is provided here.

Amiodarone HCl Injection USP and Tranexamic Acid Injection USP are used to treat different conditions. If Tranexamic acid is administered to a patient in place of Amiodarone or vice versa, it could present a risk to patient safety.

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. If treatment with Amiodarone HCl Injection, when needed, is delayed this could result in continued irregular heartbeat and potential life-threatening effects on cardiac function.

If Tranexamic Acid Injection is inadvertently administered it could result in adverse events, including blood clotting, seizures, hypersensitivity reactions, visual disturbances, and dizziness. If treatment with Tranexamic Acid Injection, when needed, is delayed this could result in limited to serious and life-threatening bleeding events.

Patients with questions regarding this recall can contact Mylan Customer Relations at 1-800-796-9526 or customer.service@mylan.com, Monday through Friday, 8:00 a.m. to 5:00 p.m. (ET). Patients should contact their physician or healthcare provider if they have experienced any problems that may be related to using these drug products.

CVS Caremark Response:

Please note: These products are not carried by the CVS Caremark® Mail Service Pharmacies.

For more information about this recall please contact Mylan Customer Relations at 1-800-796-9526, Monday through Friday, 8:00 a.m. to 5:00 p.m. (ET) or email at customer.service@mylan.com. You may also contact the FDA at 1‑888‑INFO-FDA (1‑888-463-6332).

To view the FDA notice regarding Amiodarone HCl Injection, please click on the link below:

https://www.accessdata.fda.gov

To view the FDA notice regarding Tranexamic Acid Injection, please click on the link below:

https://www.accessdata.fda.gov