Eugia US LLC recalls Tirofiban Hydrochloride Injection 12.5 mg/250 mL due to out-of-spec related substances in stability testing. This medication is prescription-only and sold in single-dose containers.
Out-of-Specification test results were obtained in at long term conditions during 3 month's stability study for related substances.
Eugia US LLC is recalling Tirofiban Hydrochloride Injection 12.5 mg/250 mL (single-dose bag) because stability testing showed related substances outside acceptable levels. This could affect medication safety for patients using this blood thinner.
The recall is based on stability testing showing related substances outside acceptable levels. This could potentially impact medication safety, though the exact risk to patients isn't specified in the recall notice.
Prescription patients using Tirofiban Hydrochloride Injection 12.5 mg/250 mL (single-dose bag) manufactured by Eugia US LLC. Those with the specific lot number 3TF24001 are most at risk.
Check for the product name Tirofiban Hydrochloride Injection 12.5 mg/250 mL (single-dose bag) with lot number 3TF24001. This medication is prescription-only and manufactured in India for Eugia US LLC.
Look for the lot number 3TF24001 on the container to confirm if it's affected.
The recall notice states that out-of-spec related substances were found in stability testing, but does not specify if the medication is unsafe for current use.
The recall notice does not provide specific action steps for affected patients.
Check the lot number on the container; affected units have lot number 3TF24001.
We’ve drafted a message you can send Eugia to request your refund or repair — edit it as you like.
Subject: Recall D-0390-2025 — Eugia Eugia Hello, I own a Eugia that is covered by recall D-0390-2025 from Eugia. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
