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TIROFIBAN
Wed May 07 2025
Summary
Out-of-Specification test results were obtained in at long term conditions during 3 month's stability study for related substances.
Product Description
| Drug | Manufacturer | Distribution Pattern | Number of Affected Units |
|---|---|---|---|
| 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 | Eugia US LLC | USA nationwide. | N/A |
| 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 | USA nationwide. | 18,867 bags |
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