85%Confidence
0Views
FDASource
2026-03-16Date
Summary
Slate Run Pharmaceuticals recall for Eptifibatide labeling error is a Class III issue, indicating a lower health risk but a potential for dosing confusion. This highlights regulatory compliance challenges in packaging and labeling, particularly with contract manufacturing.
Actionable: Verify labeling accuracy for all critical care injectables in your portfolio.
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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