FDA-Drug2025-05-07Class II
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
Eugia US LLC
Hazard
Out-of-Specification test results were obtained in at long term conditions during 3 month's stability study for related substances.
Sold states
USA nationwide.
Affected count
18,867 bags
Manufactured in
279 Princeton Hightstown Rd, N/A, East Windsor, NJ, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0389-2025Don't want to check this manually?
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