Tirofiban 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 stability testing. The affected lot was distributed nationwide.
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. The source text indicates out-of-specification test results without any reported illnesses, injuries, or deaths. The hazard is a potential quality defect detected during stability testing, making this a precautionary recall.
Plain-English summary
Eugia US LLC is recalling Tirofiban Hydrochloride Injection 5 mg/100 mL (50 mcg/mL) in 100 mL single-dose bags (NDC 55150-429-01 and 55150-430-01) nationwide. The recall affects Lot #3TF24002A with expiration date 11/30/2026, totaling 18,867 bags.
The recall was initiated because out-of-specification test results were obtained for related substances during a 3-month stability study conducted under long-term storage conditions. This indicates the product may not meet required quality standards.
Tirofiban is a prescription intravenous antiplatelet medication. Healthcare providers and patients currently using this medication should contact their pharmacy or healthcare provider for guidance. The drug is manufactured in India by Eugia US LLC, located in E. Windsor, New Jersey.
The recalled product
- Product
- TIROFIBAN (TIROFIBAN)
- Brand
- TIROFIBAN
- Manufacturer
- Eugia US LLC
- Category
- Drug — Injectable / Antiplatelet
- Hazard
- out-of-specification-quality
- related-substances-deviation
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 #: 3TF24002A
- Exp 11/30/2026
UPCs (2)
- 0355150430017
- 0355150429011
Distribution
Distributed nationwide across the United States.
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- ModerateTirofiban Hydrochloride Injection recalled for out-of-specification test results
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