Blood Thinner Recalled

AuroMedics Pharma is recalling a single lot of fondaparinux sodium injection because the drug is subpotent, according to the November 2, 2022, US Food and Drug Administration (FDA) Enforcement Report.

The recall affects fondaparinux sodium injection, 7.5 mg per 0.6 mL, single-dose, prefilled syringes (syringe NDC 55150-232-00, carton NDC 55150-232-10), from lot CFN200020 (Exp. 11/22). 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 30, 2022. On October 24, 2022, the FDA designated the recall Class II. Products affected by Class II recalls may cause temporary or medically reversible adverse health consequences if used. While remote, a possibility of serious harm also exists.

Fondaparinux sodium injection is a prescription blood thinner indicated for prophylaxis of deep vein thrombosis and the treatment of acute deep vain thrombosis and acute pulmonary embolism.