FDA-Drug2026-03-04Class IIIMISBRANDING
Slate Run Pharmaceuticals Eptifibatide Injection recalled for incorrect dosing instruction labeling
LABEL MIX UPNationwide distribution
Check Slate Run Eptifibatide Injection labeling
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.
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.
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-0343-2026Don't want to check this manually?
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