Class III
Ongoing
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
This recall is currently active, issued March 4, 2026. It was issued by Slate Run Pharmaceuticals.
- Company
- Slate Run Pharmaceuticals
- Recall Initiated
- February 12, 2026
- Posted
- March 4, 2026
- Recall Number
- D-0343-2026
- Voluntary / Mandated
- Voluntary: Firm initiated
- Firm Location
- Columbus, OH, United States
- Official Source
- View on FDA website ↗
Reason for Recall
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.
Distribution
Nationwide within the USA.
Lot / Code Info
All lots within expiry
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