Antifibrinolytic Drug Recalled

Two firms are recalling tranexamic acid tablets for failing to meet impurity/degradation specifications. According to the June 21, 2023, US Food and Drug Administration (FDA) Enforcement Report, results from drug testing were out of specification for conductivity.

The recall affects the following products, which were distributed throughout the United States:

• Lysteda (tranexamic acid) tablets, 650 mg, 30-tablet bottles (NDC 69918-301-30) manufactured for Amring Pharmaceuticals Inc., Berwyn, Pennsylvania, from lots X220317A and X220318A (Exp 9/25); and
• tranexamic acid tablets, 650 mg, 30-tablet cartons (containing three 10-tablet cards; NDC 50268-772-13) manufactured for AvKare, Pulaski, Tennessee, from lot 44286 (Exp 2/25). 

The recalls were voluntarily initiated by Amring Pharmaceuticals on June 12, 2023, and AvKare on June 13, 2023. Each was designated Class III by the FDA 2 days after it was initiated. The recall classification indicates use of the affected tablets is not likely to cause harm.

Tranexamic acid tablets are available with a prescription for the treatment of heavy menstrual bleeding.