Drug recall
Tirofiban Hydrochloride Injection 12.5 mg/250 mL (50 mcg/mL), 250 mL single-dose container (bag), Rx only…
FDA recall event 96718 · Class II · Eugia US LLC
Key facts
| Event ID | 96718 |
|---|---|
| Recall numbers | D-0389-2025, D-0390-2025 |
| Recalling firm | Eugia US LLC |
| Product type | Drugs |
| Products | 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…, 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… |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary: Firm Initiated |
| Reason for recall | Out-of-Specification test results were obtained in at long term conditions during 3 month's stability study for related substances. |
| Initiation date | Apr 21, 2025 |
| Report date | May 7, 2025 |
| City | East Windsor |
| State | NJ |
| Country | United States |
| FEI number | 3014054088 |
At a glance
- 1–9 Products in this recall
- None FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: