Tirofiban Hydrochloride Injection recalled for out-of-specification test results
Eugia US LLC is recalling Tirofiban Hydrochloride Injection due to out-of-specification test results for related substances found during a three-month stability study under long-term storage conditions.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is an FDA Class II recall involving a pharmaceutical product with out-of-specification stability test results. No illnesses, injuries, or deaths are reported in the source text, and the hazard is quality-control related rather than an acute safety threat, placing it in the Moderate category per the rubric.
Plain-English summary
Eugia US LLC is recalling Tirofiban Hydrochloride Injection, 12.5 mg/250 mL (50 mcg/mL), in 250 mL single-dose bags. The recall is based on out-of-specification test results obtained during a three-month stability study conducted under long-term storage conditions for related substances.
The affected product is Lot #3TF24001 with an expiration date of 3/31/2026. The product was distributed nationwide in the USA.
Patients receiving this medication should consult their healthcare provider or pharmacist. Do not stop taking this medication without medical guidance, as tirofiban is used to prevent blood clots in patients undergoing certain cardiac procedures. Your healthcare provider can advise on the safety of your current supply and whether alternative medication is needed.
The recalled product
- Product
- TIROFIBAN (TIROFIBAN)
- Brand
- TIROFIBAN
- Manufacturer
- Eugia US LLC
- Category
- Drug — Injectable / Antiplatelet
- Hazard
- out-of-specification
- stability-failure
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot# : 3TF24001
- Exp 3/31/2026
UPCs (2)
- 0355150430017
- 0355150429011
Distribution
Distributed nationwide across the United States.
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