89%Confidence
0Views
FDASource
2026-03-02Date
Summary
Another Fresenius Kabi Compounding recall for ketamine HCl sterility issues indicates persistent problems within its sterile compounding processes. This recurring pattern may trigger more severe FDA enforcement actions and erode customer trust in its critical care products.
Actionable: Investigate whether Fresenius Kabi's compounding quality issues are isolated or systemic, as repeated failures could signal deeper operational problems.
AI Confidence: 89%
Data Points
firmFresenius Kabi Compounding, LLC
classificationClass II
statusOngoing
distributionUS Nationwide.
productketamine HCl, 1,000 mg, 1,000 mg per 100 mL (10 mg per mL) in Sodium Chloride Injection, Fagron Sterile Services, 20 Dan Road, Canton, MA 02021, NDC 7
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