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

Recall Number: D-0389-2025

Firm: Eugia US LLC

Classification: Class II

Status: Ongoing

Report Date: 20250507

Initiation Date: 20250421

Termination Date:

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

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