Steroid Injection Recalled

More than 70 000 vials of dexamethasone sodium phosphate injection are under recall for an impurity. According to the June 26, 2024, US Food and Drug Administration (FDA) Enforcement Report, testing results for sulfonic acid adduct of dexamethasone phosphate were above specification.

The recall affects dexamethasone sodium phosphate injection, 120 mg per 30 mL (4 mg/mL), in 30-mL multiple-dose vials (NDC 55150-239-30), from lots 3DS23001 (Exp. 6/30/24), 3DS23004 (Exp. 6/30/24), 3DS23009 (Exp. 7/31/24), and 3DS23011 (Exp. 7/31/24). The drug was made in India and distributed throughout the United States by AuroMedics Pharma, East Windsor, New Jersey.

Eugia US voluntarily initiated the recall on May 23, 2024. The FDA designated the recall Class II on June 14, 2024. Per the classification, use of the product could cause temporary or medically reversible adverse health consequences or a remote possibility of serious harm.

Dexamethasone sodium phosphate injection is a prescription steroid with more than a dozen indications, including endocrine disorders, rheumatic disorders, dermatologic diseases, and ophthalmic diseases.