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🏥 FDA: Fresenius Kabi Compounding, LLC — Class II

healthcareactionableSource: FDA
85%Confidence
0Views
FDASource
2026-03-07Date

Summary

Vancomycin sterility issues at Fresenius Kabi represent the third sterility recall from this facility, indicating serious systemic problems in their compounding operations. This could lead to facility shutdown and create antibiotic supply shortages for hospitals.

Actionable: Healthcare systems should audit their Fresenius Kabi compounded medication inventories and establish alternative vancomycin sources immediately.

AI Confidence: 85%

Data Points

firmFresenius Kabi Compounding, LLC
classificationClass II
statusOngoing
distributionUS Nationwide.
productvancomycin HCl, 1.5 grams, 1.5 grams added to 500 mL, 0.9% Sodium Chloride Injection, USP, Fagron Sterile Services, 20 Dan Road, Canton, MA 02021, NDC

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