85%Confidence
0Views
FDASource
2026-03-06Date
Summary
Fresenius Kabi faces sterility assurance issues with compounded thiamine products, indicating potential contamination risks in sterile compounding operations. This could impact hospital and clinical customers relying on these critical care medications.
Actionable: Review Fresenius Kabi's compounding facility compliance and consider alternative thiamine suppliers.
AI Confidence: 85%
Data Points
firmFresenius Kabi Compounding, LLC
classificationClass II
statusOngoing
distributionUS Nationwide.
productthiamine HCl, 500 mg, 500 mg added to 100 mL, 0.9% Sodium Chloride Injection, USP, Fagron Sterile Services, 20 Dan Road, Canton, MA 02021, NDC 71506-0
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