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Class III · Lower riskActive recall

Eptifibatide

Unlikely to cause harm — often a labeling or packaging issue.

Does this affect you?
Check your lot numberAll lots within expiry
Where it was soldNationwide within the USA.
Find the lot number printed on your box or bottle. If it matches — and you take this medicine — call your pharmacist. Don't stop a prescribed medicine on your own.

What happened

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.

What to do

  1. Check the lot number and expiry on your medicine against the recall above.
  2. Talk to your pharmacist or doctor before changing anything — don't stop on your own.
  3. Report any problems to FDA MedWatch (1-800-FDA-1088 or fda.gov/medwatch).

Who makes it

Made byHainan Poly Pharm. Co., Ltd., Guilinyang Economic Development Area, Haikou, Hainan Province, China 571127; Distributed by: Slate Run Pharmaceuticals, LLC, Columbus, Ohio 43215 foreign manufacturer
Brand nameEPTIFIBATIDE
Generic nameEPTIFIBATIDE
Active ingredient(s)EPTIFIBATIDE
Distributed by / forSlate Run Pharmaceuticals, LLC, Columbus, Ohio 43215
Show the full FDA record
Full product labelEptifibatide 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
Recalling firmSlate Run Pharmaceuticals
DistributionNationwide within the USA.
QuantityN/A
Recall initiated2026-02-12
Report date2026-03-04
Recall completed—
Recall numberD-0343-2026
ClassificationClass III
FDA statusOngoing
Origin on fileColumbus OH United States

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Source: U.S. FDA enforcement database (openFDA). Look this up on the official FDA recalls site ↗

This is public FDA recall information, not medical advice. A recall does not always mean your specific bottle is affected. Never stop a prescribed medicine without asking your pharmacist or doctor.