Home / Recalls / Slate Run Pharmaceuticals / D-0343-2026

D-0343-2026 Class III Ongoing

Recalled by Slate Run Pharmaceuticals — Columbus, OH

Recall Details

Product Type: Drugs
Report Date: March 4, 2026
Initiation Date: February 12, 2026
Termination Date: N/A
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: N/A

Product Description

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.

Distribution Pattern

Nationwide within the USA.

Code Information

All lots within expiry