Slate Run Pharmaceuticals recalls Eptifibatide Injection
- Recalling company
- Slate Run Pharmaceuticals
- 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
- Reason
- 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.
- Classification
- Class III – not likely to cause adverse health consequences
- Recall date
- Feb 12, 2026
- Reported
- Mar 4, 2026
- Distribution
- Nationwide within the USA.
- Status
- Ongoing
- Quantity
- N/A
- Lot / codes
- All lots within expiry
- Company location
- Columbus, OH
- Recall type
- Voluntary: Firm initiated
- Recall number
- D-0343-2026
- Agency
- U.S. Food and Drug Administration (FDA)
View official FDA notice ↗ Search recall number D-0343-2026 in the FDA Enforcement Report. Also see FDA recall press releases.
If you use this product, check the lot, NDC or model number against the official notice and follow its instructions. Do not stop a prescribed medicine or remove a medical device without talking to your doctor or pharmacist. Report problems to FDA MedWatch. FoodRecallNow summarizes public FDA data and is not medical advice.