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
Reason for recall: Out-of-Specification test results were obtained in at long term conditions during 3 month's stability study for related substances.
Recall initiated: 20250421
Status: Ongoing
Classification: Class II
Recall type: Voluntary: Firm initiated