FDA-Drug2026-03-04Class IIIMISBRANDING

Slate Run Pharmaceuticals Eptifibatide Injection recalled for incorrect dosing instruction labeling

LABEL MIX UPNationwide distributionDrugs

What this means

Slate Run Pharmaceuticals is recalling Eptifibatide Injection 75 mg/100 mL vials because the carton label says "weight-adjusted bolus dosing" when it should say "weight-adjusted infusion." This labeling error could lead to incorrect administration of the medication. No injuries have been reported.

  • If you are a healthcare provider or facility using this medication, verify the correct dosing method is weight-adjusted infusion, not bolus dosing.
  • Contact Slate Run Pharmaceuticals or your pharmacy if you have questions about proper administration.
  • Do not use this medication until you confirm the correct dosing instructions with your healthcare provider or pharmacist.
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The agency's original wording
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.

Intended for
Adults
Illnesses reported
None reported
Sold states
Nationwide within the USA.
Affected count
N/A
Manufactured in
277 W Nationwide Blvd Ste 260, N/A, Columbus, OH, United States
Products
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

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0343-2026

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