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
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 was recalled because 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.. If you have this product, stop using it until you verify your lot or model details.
By RecallRadar Editorial Team
Sourced from FDA. Last verified March 15, 2026.
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- Date announced
- March 4, 2026
- Source agency
- FDA
This recall involves safety concerns. Take action promptly.
✨ Plain-English Summary
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 was recalled because 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.. If you have this product, stop using it until you verify your lot or model details.
Is This Recall Still Active?
Status: Yes - Active
This recall is currently active. If your device matches the affected models, follow the official instructions as soon as possible.
What's Being Recalled
Quoted source excerpt from the official notice.
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.
Quick Info
Key facts from the official notice, kept in the article flow for easy cross-checking.
- Brand
- Eptifibatide
- Category
- drug
- Source agency
- FDA
- Announced
- March 4, 2026
- Country
- US
- Status
- Active
Who's Affected
Specific models and identifiers listed in the source notice:
Model #1
All lots within expiry
| # | Model |
|---|---|
| 1 | All lots within expiry |
Technical model codes are manufacturer identifiers. Match both the product name and model code from your device settings, label, or packaging.
What You Should Do
Follow the remedy path from the official notice using the exact model and serial details above.
- 1Stop using the affected product until you verify whether your item is impacted.
- 2Check the official recall notice and match your model, lot, or serial details.
- 3Follow the official instructions for repair, replacement, refund, or disposal.
Source & Verification
This page summarizes the official notice and keeps key facts easy to verify.
- Official source
- FDA
- Announced by source
- March 4, 2026
- Last reviewed by RecallRadar
- March 15, 2026
Frequently Asked Questions
Am I affected by this recall?
Check the affected models section on this page. The official notice currently lists All lots within expiry.
What is the remedy for this recall?
Follow the official instructions for repair, replacement, refund, or disposal on the eptifibatide recall page.
Where can I verify recall details?
Use the official source link in this page to confirm dates, eligibility, and next steps: https://api.fda.gov/drug/enforcement.json?search=recall_number:D-0343-2026&limit=1
Keep browsing with these internal hubs: eptifibatide recall hub and Food & Drug recall hub.
Official Resources
Use these primary sources for final eligibility and claim instructions.
View official notice from FDASee an inaccuracy?
Help us improve the accuracy of this recall information.
On this page
Free checker
Check if you qualify
See whether your device may qualify for a free repair or replacement program before you spend money.
Check if you qualifyKey facts
- Date announced
- March 4, 2026
- Source agency
- FDA
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