FDAHealthFebruary 12, 2026
Slate Run Pharmaceuticals — 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
⚠️ 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.
Is this relevant to me?
- Geography
- Nationwide
- Source agency
- FDA
- Category
- Health
- Published
- February 12, 2026
Nationwide within the USA.
What's affected?
- Product
- 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
- Brand
- EPTIFIBATIDE
- UPC
- 0370436027804
- Lot code
- within
Additional details
All lots within expiry
What should I do?
Recommended action
Class III recall. Voluntary: Firm initiated Quantity affected: N/A.
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