Antifibrinolytic Injection Recalled

A piece of metal found in a vial has prompted AuroMedics Pharma to recall 88,080 vials of tranexamic acid injection, according to the October 12, 2022, US Food and Drug Administration (FDA) Enforcement Report.

The recall affects tranexamic acid injection, 1000 mg/mL (100 mg/10 mL), 10-mL single-dose vials (NDC 55150-188-10), from lot CTA210006 (Exp. 2/24). The product was made in India and distributed by AuroMedics Pharma, East Windsor, NJ, throughout the United States.

AuroMedics Pharma voluntarily initiated the recall September 26, 2022. On September 30, 2022, the FDA designated the recall Class III, suggesting use of the recalled injection is not likely to cause harm.

Tranexamic acid injection is a prescription antifibrinolytic indicated in patients with hemophilia to reduce or prevent bleeding during dental procedures.