Class II โ€” Potential Health Hazard

Potential health hazard โ€” use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

Tirofiban Hydrochloride Injection 5 mg/100 mL (50 mcg/mL) Recalled by Eugia US LLC Due to Out-of-Specification test results were obtained in at long...

Date: April 21, 2025
Company: Eugia US LLC
Status: Ongoing
Source: FDA (Drug)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Eugia US LLC directly.

Affected Products

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

Quantity: 18,867 bags

Why Was This Recalled?

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

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Eugia US LLC

Eugia US LLC has 16 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report