80%Confidence
0Views
FDASource
2026-03-07Date
Summary
Fresenius Kabi's compounding facility faces sterility assurance issues with thiamine products, potentially compromising patient safety and inviting regulatory sanctions. This may affect Fresenius's compounding business reputation and increase scrutiny on hospital compounding practices.
Actionable: Review Fresenius Kabi's compounding segment performance and consider diversifying pharmaceutical compounding exposure.
AI Confidence: 80%
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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