FDA-Drug2026-03-04Class IIIMISBRANDING
Slate Run Pharmaceuticals Eptifibatide Injection recalled for incorrect dosing instruction labeling
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.
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-0343-2026Want us to check the next one for you?
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