Mylan recalls injectables over carton label switch

Aug. 31, 2020

Mylan is conducting a voluntary nationwide recall to the hospital/clinic level of two different injectables after determining the carton labels may be switched.

The U.S.-based drugmaker is recalling four 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.

Amiodaron is an antiarrhythmic that helps regulate heartbeat in patients with heart rhythm disorders. Tranexamic acid is given to patients with hemophilia to prevent hemorrhage following tooth extraction.

While the individual vials contained within the cartons are accurately labeled, the cartons may not be, says Mylan. According to the drugmaker, inadvertently switching the injections could be dangerous: If administered by mistake, Amiodarone 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. Tranexamic could result in adverse events, including blood clotting, seizures, hypersensitivity reactions, visual disturbances, and dizziness.

Read the press release