Where it's made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Hainan Poly Pharm. Co., Ltd. | Haikou, China | Makes it, tests it and packages it | Problems found, fixed voluntarilyJun 30, 2023 · 4 inspections |
Recalls
- Feb 12, 2026 · Class III · Slate Run Pharmaceuticals
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: All lots within expiry
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.
Product details
- Generic drug
- Eptifibatide: every company that makes it
- Form
- injection, intravenous
- Strength
- 2 mg per 1 mL
- Approval
- ANDA ANDA209864
- On the market since
- Jul 22, 2019
- Package NDCs
70436-026-80- Official label
- DailyMed (National Library of Medicine), updated Feb 9, 2026
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