Multi event Drug Recall Enforcement Report Class II voluntary initiated by Eugia US LLC, originally initiated on 04-21-2025 for the 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 The product was recalled due to out-of-specification test results were obtained in at long term conditions during 3 month's stability study for related substances.. The product was distributed nationwide and the recall is currently ongoing.
Recall Enforcement Reports
| Recall Number |
Recall Initiation Date |
Report Date |
Recall Classification |
Quantity |
Product Description |
Recall Reason |
Status |
| D-0389-2025 | 04-21-2025 | 05-07-2025 | Class II | 18,867 bags | 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 | Out-of-Specification test results were obtained in at long term conditions during 3 month's stability study for related substances. | Ongoing |
| D-0390-2025 | 04-21-2025 | 05-07-2025 | Class II | N/A | 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 | Out-of-Specification test results were obtained in at long term conditions during 3 month's stability study for related substances. | Ongoing |
Recalled Products
| NDC |
Proprietary Name |
Non-Proprietary Name |
Dosage Form |
Route Name |
Company Name |
Product Type |
| 55150-429 | Tirofiban | Tirofiban | Injection, Solution | Intravenous | Eugia Us Llc | Human Prescription Drug |
| 55150-430 | Tirofiban | Tirofiban | Injection, Solution | Intravenous | Eugia Us Llc | Human Prescription Drug |
