# FDA recall D-0389-2025

> **Eugia US LLC** · Class II · drug recall initiated 2025-04-21.

## 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

## Reason for recall

Out-of-Specification test results were obtained in at long term conditions during 3 month's stability study for related substances.

## Distribution

USA nationwide.

## Key facts

- **Recall number:** D-0389-2025
- **Recalling firm:** Eugia US LLC
- **Classification:** Class II
- **Product type:** drug
- **Status:** Ongoing
- **Initiation date:** 2025-04-21
- **Report date:** 2025-05-07

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** East Windsor, NJ, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0389-2025

## Citation

> AI Analytics. FDA recall D-0389-2025. Retrieved 2026-07-04 from https://api.ai-analytics.org/recall/D-0389-2025. Source: US FDA. Licensed CC0.

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