Drug recall D-0343-2026
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 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.
Lots and codes
All lots within expiry
Recall details
- Recalling firm
- Slate Run Pharmaceuticals, Columbus, OH
- Quantity
- N/A
- Distribution
- Nationwide within the USA.
- Type
- Voluntary: Firm initiated
- Recall initiated
- February 12, 2026
Related products
- Eptifibatide – drug information
- NDC 70436-027 Eptifibatide · Eptifibatide .75 mg/mL · Slate Run Pharmaceuticals, LLC
- NDC 70436-162 Eptifibatide · Eptifibatide 2 mg/mL · Slate Run Pharmaceuticals, LLC
- NDC 70436-163 Eptifibatide · Eptifibatide .75 mg/mL · Slate Run Pharmaceuticals, LLC
- NDC 70436-026 Eptifibatide · Eptifibatide 2 mg/mL · Slate Run Pharmaceuticals, LLC