Mylan Recalls Certain Lots Of Amiodarone HCl, Tranexamic Acid Injections

(RTTNews) - Generic and specialty pharma company Mylan N.V. said its U.S.-based business Mylan Institutional LLC recalled four lots of Amiodarone HCl Injection, USP and Tranexamic Acid Injection, USP for potential interchanging of cartons, according to the U.S. Food and Drug Administration or FDA.

The recall involves 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.

The company said cartons labeled as Tranexamic Acid Injection, USP could contain vials of Amiodarone HCl Injection, USP, while cartons labeled as Amiodarone HCl Injection, USP could to contain vials of Tranexamic Acid Injection, USP. However, the individual vials contained within the cartons are accurately labeled as Amiodarone HCl Injection, USP or Tranexamic Acid Injection, USP.

These injection lots were distributed to wholesalers and hospital/clinical pharmacies across the U.S. between April 2020 and July 2020, with expiry dates of November 2021 and December 2021.

Mylan said it is notifying its wholesalers and hospital/clinic pharmacies by letter and is arranging for return of recalled products to Stericycle. It has warned those having the recalled product to stop use or further distribution or dispensing.

However, Mylan confirmed that it is yet to receive any reports of adverse events involving the recalled injections.

Amiodarone HCl Injection, USP is an antiarrhythmic agent, while Tranexamic acid injection is indicated in patients with haemophilia to reduce or prevent hemorrhage.

The company said 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.

The company warned that the wrong administration of Amiodarone HCl Injection 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 Tranexamic Acid Injection is inadvertently administered it could result in adverse events, including blood clotting, seizures, hypersensitivity reactions, visual disturbances, and dizziness.

In July, Mylan Institutional had also recalled one lot of bacterial infection antibiotic Daptomycin in the form of injection, 500 mg/vial packaged in 20 mL vial, for the potential presence of particulate matter, according to the FDA.

In January, Mylan Pharmaceuticals, another U.S.-based business of Mylan N.V., had recalled three lots of ulcer medication Nizatidine Capsules, USP, of 150mg and 300mg strengths of 30 and 60 count bottles for the potential presence of nitrosamine impurity, N-Nitrosodimethylamine (NDMA).