FDARecalled May 7, 2025 · #D-0389-2025
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...
Hazard
Class II — temporary health risk
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Out-of-Specification test results were obtained in at long term conditions during 3 month's stability study for related substances. Classification: Class II Distribution: USA nationwide.
Product details
- 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
- Type
- Drugs
- Manufacturer
- Eugia US LLC
- Model numbers
- 3TF24002A
- UPCs
- —