Glucocorticoid Injection Recalled

Eugia US is recalling 10,080 vials of methylprednisolone acetate injectable suspension for failing to meet dissolution specifications, according to the March 13, 2024, US Food and Drug Administration (FDA) Enforcement Report.

The recall affects methylprednisolone acetate injectable suspension, 400 mg per 5 mL (80 mg/mL), 5-mL multiple-dose vials (NDC 55150-314-01), from lots 3MA23001, 3MA23002, and 3MA23003 (Exp. 3/31/25). The product was manufactured in India for Eugia US, East Windsor, New Jersey, and was distributed in Ohio, Tennessee, Louisiana, and Mississippi. 

Eugia US voluntarily initiated the recall on February 20, 2024. The FDA designated the recall Class III on March 4, 2024. The classification communicates that use of the affected product is not likely to cause harm.

Methylprednisolone acetate injectable suspension is a prescription anti-inflammatory glucocorticoid for intramuscular, intra-articular, soft tissue, or intralesional injection. It is used to treat numerous conditions that involve inflammation.