Slate Run Pharmaceuticals: Eptifibatide Injection, 75 mg/100 mL vial for weight-adjusted bolus dosing, 1x100 mL Single-dose Vial, For Intravenous Use Only, Rx Only, Ma
Read the official notice at FDA (drug) →
The text below is copied from the official FDA (drug) record. If anything differs, the official notice is correct.
- Company / brand
- Slate Run Pharmaceuticals
- 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 / hazard
- 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.
- Classification
- Class III
- Status
- Ongoing
- Distribution / sold at
- Nationwide within the USA.
- Recall initiated
- 2026-02-12
- Code info
- All lots within expiry
- Product quantity
- N/A
- Voluntary mandated
- Voluntary: Firm initiated
- City
- Columbus
- State
- OH
- Country
- United States
- Event id
- 98416
Free daily digest + "My products" watchlist