TIROFIBAN HYDROCHLORIDE Recall D-0390-2025
Description: 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
TIROFIBAN HYDROCHLORIDE Recall D-0390-2025 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | D-0390-2025 |
| Event ID | 96718 |
| Brand | TIROFIBAN |
| Generic Name | TIROFIBAN |
| Manufacturer | TIROFIBAN |
| Original Package? | 1 |
| Active Substance | TIROFIBAN HYDROCHLORIDE |
| Drug Route | INTRAVENOUS |
| Distribution | USA nationwide. |
| Quantity | N/A |
| Recall Reason | Out-of-Specification test results were obtained in at long term conditions during 3 month's stability study for related substances. |
| Drug Classification | Class II |
| Drug Code Info | 20250507 |
| Product NDC | 55150-429 55150-430 |
| Drug UPC | 0355150430017 0355150429011 |
| Recall Initiation Date | 20250421 |
| Report Date | 20250507 |
| Classification Date | 20250425 |
| Address | 279 Princeton Hightstown RdN/A East Windsor, NJ 08520-1401 United States |
| Recalling Firm | Eugia US LLC |
| Initial Notification | Letter |
| Unique Ingredient Identifier | 6H925F8O5J |
| Drug Application Number | ANDA216379 |
| Structured Product Labeling (SPL ID) | 1751523a-e22e-4faf-bdb1-c850afe2fd36 |
| Structured Product Labeling (SPL Set ID) | d554acff-22e9-4f28-b826-ee1b91daa2df |
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