Slate Run Pharmaceuticals Recalls Eptifibatide Injection Nationwide Over Carton Labeling Error

Key Takeaways

• Slate Run Pharmaceuticals is voluntarily recalling all lots within expiry of eptifibatide injection, 75 mg/100 mL single-dose vials, distributed nationwide.
• The Class III recall was initiated due to a labeling error: the carton states “weight-adjusted bolus dosing” instead of the US Food and Drug Administration (FDA)-approved “weight-adjusted infusion.” No contamination or potency issues were reported.
• Eptifibatide, a glycoprotein IIb/IIIa inhibitor, is indicated for acute coronary syndrome and patients undergoing percutaneous coronary intervention (PCI) to reduce thrombotic cardiovascular events.

Slate Run Pharmaceuticals is recalling eptifibatide injection, 75 mg/100 mL, supplied in a 1x100 mL single-dose vial for intravenous use only. The product is manufactured by Hainan Poly Pharm. Co, Ltd, located in Haikou, Hainan Province, China, and distributed nationwide within the US by Slate Run Pharmaceuticals, LLC, of Columbus, Ohio. The affected product includes all lots within expiry. The recall, identified as number D-0343-2026 (event ID 98416), was initiated on February 12, 2026, with the FDA classifying the action on February 23, 2026. The recall remains ongoing and was communicated to consignees via letter. No press release has been issued.

The recall has been designated as a Class III action, indicating that use of or exposure to the violative product is not likely to cause adverse health consequences. The issue prompting the recall involves labeling. Specifically, the carton label for eptifibatide injection incorrectly states “75 mg/100 mL vial for weight-adjusted bolus dosing,” whereas the FDA-approved labeling should read “75 mg/100 mL vial for weight-adjusted infusion.” The discrepancy falls under “Labeling: Not Elsewhere Classified.” Although the error is not associated with product contamination or potency concerns, pharmacists should be aware of the labeling inconsistency to prevent potential confusion in dosing and administration.

Eptifibatide is a glycoprotein IIb/IIIa inhibitor indicated for the treatment of patients with acute coronary syndrome, including unstable angina and non–ST-segment elevation myocardial infarction, as well as for patients undergoing percutaneous coronary intervention PCI. It works by inhibiting platelet aggregation, thereby reducing the risk of thrombotic cardiovascular events. Pharmacists should ensure that appropriate dosing and administration practices are followed in accordance with the approved infusion-based labeling.

Reference

FDA. Enforcement Report. February 23, 2026. Accessed February 26, 2026. https://www.accessdata.fda.gov/scripts/ires/index.cfm