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🏥 FDA: Fresenius Kabi USA, LLC — Class II

healthcarebearishSource: FDA
85%Confidence
0Views
FDASource
2026-04-20Date

Summary

Fresenius Kabi's sterility recall extends to a larger volume saline product, suggesting widespread contamination risks. This may necessitate a comprehensive manufacturing overhaul and increased capital expenditures.

Actionable: Consider reducing exposure to Fresenius Kabi until the scope of the manufacturing issues is fully understood.

AI Confidence: 85%

Data Points

firmFresenius Kabi USA, LLC
classificationClass II
statusOngoing
distributionUS Nationwide , Alaska, and Puerto Rico.
product0.9% Sodium Chloride Injection, USP 900 mg per 100 mL (9 mg per mL) 500 mL in a Single Dose freeflex bag, 500 mL x 20, Manufactured for: Fresenius Kab

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