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.
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
Lot numbers, UPCs & expiration codes
All lots within expiry
Where it was sold
Nationwide within the USA.
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0343-2026
- Classification
- Class III
- Status
- Ongoing
- Recall initiated
- Feb 12, 2026
- FDA report date
- Mar 4, 2026
- Quantity
- N/A
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Slate Run Pharmaceuticals
Original FDA data
Every field from FDA enforcement report D-0343-2026, exactly as published.
Show all FDA fields
- City
- Columbus
- State
- OH
- Status
- Ongoing
- Country
- United States
- Event ID
- 98416
- Address
- 277 W Nationwide Blvd Ste 260
- Code information
- All lots within expiry
- Postal code
- 43215-0169
- Report date
- Mar 4, 2026
- Product type
- Drugs
- Recall number
- D-0343-2026
- Classification
- Class III
- Recalling firm
- Slate Run Pharmaceuticals
- 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.
- Voluntary / mandated
- Voluntary: Firm initiated
- 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
- Distribution pattern
- Nationwide within the USA.
- Recall initiation date
- Feb 12, 2026
- Initial firm notification
- Letter
- Center classification date
- Feb 23, 2026