FDA Drugs recall ·
Eptifibatide Injection, 75 mg/100 mL vial for weight-adjusted bolus… recall
- Recall number
- D-0343-2026
- Date
- (initiated February 12, 2026)
- Company / brand
- Slate Run Pharmaceuticals
277 W Nationwide Blvd Ste 260, Columbus, OH, United States - Category
- Drugs › Class III
- Classification
- Class III
- Status
- Ongoing
- Units affected
- N/A
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
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
Why was it recalled?
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.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
All lots within expiry
Distribution
Nationwide within the USA.
What does Class III mean?
Class III means use of or exposure to the product is not likely to cause adverse health consequences (for example, a labeling violation).
Source: FDA (drugs), recall D-0343-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.