Class II Recall

Eugia US LLC

Product
Tirofiban Hydrochloride Injection 12.5 mg/250 mL (50 mcg/mL), 250 mL single-dose container (bag), Rx only, Manufactured in India for: Eugia U.S. LLC, 279 Princeton-Hightstown Rd., E. Windsor, NJ 08520, NDC 55150-430-01
Reason
Out-of-Specification test results were obtained in at long term conditions during 3 month's stability study for related substances.
Classification
Class II
Status
Ongoing
Lot
Lot# : 3TF24001, Exp 3/31/2026
Date
Disclaimer: This tool indexes published US FDA drug-enforcement recall records from all countries, limited to the latest five years. A company or product not appearing here is not proof that it is compliant, approved, safe, or free of FDA action.
Eugia US LLC — Class II Recall | MedicineWatch US