Injection Recalled for Particulate Matter

The presence of particulate matter has prompted Sagent Pharmaceuticals to recall more than 14,000 vials of methylprednisolone acetate injectable suspension. According to the May 22, 2024, US Food and Drug Administration (FDA) Enforcement Report, there is a potential for black particulates in the recalled vials.

The recall affects methylprednisolone acetate injectable suspension, 400 mg per 10 mL (40 mg per mL), in 10-mL multi-dose vials (NDC 25021-820-10), from lots 5100186, 5100187, 5100188, and 5100189 (Exp. 1/31/25). The product was manufactured in India for Sagent Pharmaceuticals, Schaumburg, Illinois, and was distributed throughout the United States.

Sagent Pharmaceuticals voluntarily initiated the recall on April 25, 2024. The FDA deemed the recall Class II on May 15, 2024. The recall classification signals that use of the product could cause temporary or medically reversible adverse health consequences. A remote possibility of serious harm also exists.

Methylprednisolone acetate injectable suspension is a prescription anti-inflammatory glucocorticoid drug for intramuscular, intra-articular, soft tissue, or intralesional injection. It has numerous indications, including rheumatic disorders, allergic states, and dermatologic diseases.