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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Drug
Medications & Supplements/Prescription Drugs

Eugia Tirofiban Hydrochloride Injection Recalled for Failed Stability Testing

Agency Publication Date: April 25, 2025
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Summary

Eugia US LLC is recalling approximately 18,867 bags of Tirofiban Hydrochloride Injection, a medication used to prevent blood clots in the heart. This recall affects both the 5 mg/100 mL and 12.5 mg/250 mL strengths after laboratory testing showed that certain impurities reached levels that exceeded quality standards during long-term storage. If you have any health concerns related to this medication, please contact your healthcare provider or pharmacist immediately.

Risk

Testing revealed that the medication developed impurities (related substances) that did not meet quality specifications over time. These impurities could potentially lead to unexpected side effects or reduce the effectiveness of the treatment.

What You Should Do

  1. This recall affects Tirofiban Hydrochloride Injection sold in 100 mL and 250 mL single-dose bags under the Eugia U.S. LLC brand.
  2. Identify the affected products by checking for NDC 55150-429-01 (Lot 3TF24002A, Exp 11/30/2026) or NDC 55150-430-01 (Lot 3TF24001, Exp 3/31/2026) printed on the bag or outer packaging.
  3. Stop using the recalled product immediately. Contact the manufacturer, Eugia US LLC, or your medical distributor to arrange for the return of any remaining stock.
  4. Call the FDA Consumer Complaint hotline at 1-888-723-3332 for more information or to report any adverse events.

Your Remedy Options

๐Ÿ“‹Other Action
How to: Stop using the recalled product. Contact the manufacturer or your distributor to arrange return.

Affected Products

Product: Tirofiban Hydrochloride Injection 5 mg/100 mL (50 mcg/mL)
Variants: 100 mL single-dose container (bag)
Lot Numbers:
3TF24002A (Exp 11/30/2026)
NDC:
55150-429-01

Recall #: D-0389-2025; Quantity: 18,867 bags

Product: Tirofiban Hydrochloride Injection 12.5 mg/250 mL (50 mcg/mL)
Variants: 250 mL single-dose container (bag)
Lot Numbers:
3TF24001 (Exp 3/31/2026)
NDC:
55150-430-01

Recall #: D-0390-2025

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 96718
Status: Active
Manufacturer: Eugia US LLC
Sold By: Hospitals; Infusion Centers; Wholesalers
Manufactured In: India
Units Affected: 18,867 bags
Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.