Eugia US LLC recalls Tirofiban Hydrochloride Injection 5 mg/100 mL (50 mcg/mL), 100 mL single-dose container (bag), Rx only, Manufactured in…

Recall date

April 21, 2025

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

D-0389-2025

FDA classification

Class II

Brand / firm

Eugia US LLC

Sold / distributed

USA nationwide.

Why it was recalled

Out-of-Specification test results were obtained in at long term conditions during 3 month's stability study for related substances.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Tirofiban Hydrochloride Injection 5 mg/100 mL (50 mcg/mL), 100 mL single-dose container (bag), Rx only, Manufactured in India for: Eugia U.S. LLC, 279 Princeton-Hightstown Rd., E. Windsor, NJ 08520, NDC 55150-429-01