Eugia US LLC recalls Tirofiban Hydrochloride Injection 5 mg/100 mL (50 mcg/mL), 100 mL single-dose container (bag), Rx only, Manufactured in
Recalled May 7, 2025 · FDA recall D-0389-2025 · Eugia US
Hazard
Out-of-Specification test results were obtained in at long term conditions during 3 month's stability study for related substances. · FDA Class II
Units
18,867 bags
Sold at
USA nationwide.
Description
Out-of-Specification test results were obtained in at long term conditions during 3 month's stability study for related substances.
Product
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
Manufacturer(s)
Eugia US LLC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →