Recalls / Class III
Class IIID-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
- Brand name
- Eptifibatide
- Generic name
- Eptifibatide
- Active ingredient
- Eptifibatide
- Route
- Intravenous
- NDCs
- 70436-026, 70436-027, 70436-162, 70436-163
- FDA application
- ANDA209864
- Affected lot / code info
- All lots within expiry
Why it was 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.
Recalling firm
- Firm
- Slate Run Pharmaceuticals
- Manufacturer
- Slate Run Pharmaceuticals, LLC
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 277 W Nationwide Blvd Ste 260, N/A, Columbus, Ohio 43215-0169
Distribution
- Quantity
- N/A
- Distribution pattern
- Nationwide within the USA.
Timeline
- Recall initiated
- 2026-02-12
- FDA classified
- 2026-02-23
- Posted by FDA
- 2026-03-04
- Status
- Ongoing
Source: openFDA Drug Enforcement endpoint. Recall record D-0343-2026. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.