85%Confidence
0Views
FDASource
2026-03-11Date
Summary
Class III recall for Slate Run Pharmaceuticals due to labeling error on Eptifibatide Injection indicates a low-risk but important regulatory compliance issue. The correction from 'bolus dosing' to 'infusion' clarifies proper use but is unlikely to affect clinical safety significantly.
Actionable: Verify that inventory and prescribing information for Eptifibatide Injection reflect the corrected labeling to avoid any administrative confusion.
AI Confidence: 85%
Data Points
firmSlate Run Pharmaceuticals
classificationClass III
statusOngoing
distributionNationwide within the USA.
productEptifibatide Injection, 75 mg/100 mL vial for weight-adjusted bolus dosing, 1x100 mL Single-dose Vial, For Intravenous Use Only, Rx Only, Manufactured
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