United StatesEptifibatide Injection 75 mg/100 mL single‑dose vial (1x100 mL), manufactured by Hainan Poly Pharm. Co., Ltd. and distributed by Slate Run Pharmaceuticals (Carton NDCs: 70436-027-80 and 70436-163-80), sold nationwide in the U.S., all lots within expiry, is affected. It was recalled because the carton labeling states “for weight‑adjusted bolus dosing” but the approved labeling is “for weight‑adjusted infusion.”
What's being recalled
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
Recalling firm: Slate Run Pharmaceuticals, Columbus, OH, United States.
How to identify it
All lots within expiry
The hazard
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.
What to do
Don't stop taking a prescribed medicine without talking to your doctor or pharmacist first. For other products, stop using them and ask the pharmacist, seller or maker what to do.
The notice doesn't give instructions for consumers, so this is general advice for health & beauty recalls. Check the official notice for the details.
Where it was sold
Nationwide within the USA.
The official notice
This page is a summary of the notice published by U.S. Food and Drug Administration (enforcement reports), collected from U.S. Food and Drug Administration (enforcement reports). Check the original before you act on it.
Read the official notice (opens in a new tab)