Eptifibatide Injection 75 mg/100 mL
Slate Run Pharmaceuticals recalls Eptifibatide Injection 75 mg/100 mL vials (NDC 70436-027-80, 70436-163-80) due to incorrect dosing-route labeling.
If you have received this product, contact Slate Run Pharmaceuticals immediately. Do not use the product until you have confirmed the correct dosing route with your healthcare provider or pharmacist.
Why it was recalled
Slate Run Pharmaceuticals is recalling Eptifibatide Injection, 75 mg/100 mL vials (NDC 70436-027-80 and NDC 70436-163-80) due to incorrect labeling. The carton states the vial is for weight-adjusted bolus dosing, but the approved labeling specifies weight-adjusted infusion. This mislabeling could lead to incorrect drug administration.
Is mine affected?
Check the NDC or UPC and strength printed on the package. Yours is affected if it matches one below.
Eptifibatide Injection, 75 mg/100 mL vial for weight-adjusted bolus dosing, 1x100 mL Single-dose Vial, For Intravenous Use Only, Rx Only, Manufactured by: Hainan Poly Pharm. Co., Ltd., Guilinyang Economic Development Area, Haikou, Hainan Province, China 571127; Distributed by: Slate Run Pharmaceuticals, LLC, Columbus, Ohio 43215. NDC Slate Run Carton Label: 70436-027-80; NDC ProRx Carton Label: 70436-163-80
- Recall #
- D-0343-2026
Where it was sold
Distributed nationwide.
Official source
Editorial summary by Recall Canary · last updated 2026-04-27 · primary source: U.S. Food and Drug Administration · severity reflects the agency's published classification