Slate Run Pharmaceuticals recalls Eptifibatide Injection vials due to incorrect labeling for weight-adjusted dosing. The product states 'bolus' but should be 'infusion' for safe use. No remedy specified in 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.
Slate Run Pharmaceuticals recalled Eptifibatide Injection vials because the labeling incorrectly states 'weight-adjusted bolus dosing' instead of 'weight-adjusted infusion dosing'. This could lead to improper dosing if healthcare providers follow the incorrect label.
The product label incorrectly states 'weight-adjusted bolus dosing' when the approved statement is 'weight-adjusted infusion dosing'. This could cause healthcare providers to administer the medication incorrectly if they rely on the label for dosing instructions.
Healthcare providers using Eptifibatide Injection for intravenous administration in the U.S. are likely affected. Patients receiving the medication under medical supervision are at minimal risk due to the label error being a labeling issue, not a safety hazard.
Check for Eptifibatide Injection 75 mg/100 mL vials with the NDC numbers 70436-027-80 or 70436-163-80. The product was distributed by Slate Run Pharmaceuticals in the U.S. and is for intravenous use only.
Verify the product label states 'weight-adjusted infusion dosing' instead of 'weight-adjusted bolus dosing'.
The recall is due to a labeling error, not a safety hazard. Healthcare providers should follow standard dosing practices, but the label error could lead to incorrect dosing if not addressed.
The official notice does not specify a remedy. Check the label to ensure it states 'weight-adjusted infusion dosing' for safe use.
The recall is for labeling accuracy, not a safety hazard. No serious injury risk is described in the official notice.
We’ve drafted a message you can send Slate Run Pharmaceuticals to request your refund or repair — edit it as you like.
Subject: Recall D-0343-2026 — Slate Run Pharmaceuticals Slate Run Pharmaceuticals Hello, I own a Slate Run Pharmaceuticals that is covered by recall D-0343-2026 from Slate Run Pharmaceuticals. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
