Slate Run Pharmaceuticals recalled Eptifibatide Injection on February 12, 2026. The recall affects all lots of the 75 mg/100 mL vial due to incorrect dosing information. Healthcare providers and consumers must stop using the product immediately.
Labeling: Not Elsewhere Classified. The carton for Eptifibatide Injection 75 mg/100 mL states 75 mg/100 mL vial for weight-adjusted bolus dosing. The approved statement is 75 mg/100 mL vial for weight-adjusted infusion.
Consumers and healthcare providers should stop using this product immediately. Contact Slate Run Pharmaceuticals or your healthcare provider for guidance. Notification method: Letter
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Eptifibatide Injection is a medication used in healthcare settings as an anticoagulant. It is typically administered intravenously during procedures to prevent blood clots.
The product's labeling error can lead to incorrect dosing, which may affect patient safety during treatment. Administering a bolus dose instead of an infusion can lead to serious complications.
This recall is not part of a broader industry pattern.
Consumers must stop using the product immediately, which could impact treatment plans for patients. The urgency to correct the labeling can lead to temporary disruptions in care.
The NDC numbers can be found on the carton label or the product packaging itself.
Expect a timeline of 4-6 weeks for refund processing after returning the product.
Keep records of your purchase, correspondence with the manufacturer, and photographs of the product for your records.
Eptifibatide Injection comes in a 75 mg/100 mL single-dose vial for intravenous use. It is manufactured by Hainan Poly Pharm. Co., Ltd., and distributed by Slate Run Pharmaceuticals. The product carries NDC numbers 70436-027-80 and 70436-163-80.
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