Eugia US LLC recalls Tirofiban Hydrochloride Injection 5 mg/100 mL due to out-of-spec related substances test results from stability studies. 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 5 mg/100 mL (50 mcg/mL) because stability testing showed related substances were outside acceptable levels. This could affect medication safety for patients using this blood thinner.
The recall is based on stability testing showing related substances were outside acceptable levels. This could potentially affect the medication's safety and effectiveness, though the exact risk to patients is not specified in the recall notice.
Prescription patients using Tirofiban Hydrochloride Injection 5 mg/100 mL for blood thinning. Those with the specific lot number 3TF24002A are at risk.
Check for the product name Tirofiban Hydrochloride Injection 5 mg/100 mL (50 mcg/mL) in single-dose containers. Look for the lot number 3TF24002A on the packaging.
Verify the product name and lot number on the packaging to confirm if it matches the recalled items.
The recall notice states that out-of-spec related substances were found in stability testing, but does not specify if the product is unsafe for current use.
The recall notice does not provide specific action steps for affected users.
Check the product name and lot number on the packaging; the recalled product is Tirofiban Hydrochloride Injection 5 mg/100 mL with lot number 3TF24002A.
We’ve drafted a message you can send Eugia to request your refund or repair — edit it as you like.
Subject: Recall D-0389-2025 — Eugia Eugia Hello, I own a Eugia that is covered by recall D-0389-2025 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.
