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🏥 FDA: Fresenius Kabi USA, LLC — Class II

healthcarebearishSource: FDA
80%Confidence
0Views
FDASource
2026-04-21Date

Summary

A recall of a 100mL sodium chloride injection adds to Fresenius Kabi's growing list of sterility problems, potentially affecting hospital and clinical customers. This may trigger inventory shortages and alternative sourcing by healthcare providers.

Actionable: Track hospital purchasing patterns for saline products to identify market share shifts away from Fresenius Kabi.

AI Confidence: 80%

Data Points

firmFresenius Kabi USA, LLC
classificationClass II
statusOngoing
distributionUS Nationwide , Alaska, and Puerto Rico.
product0.9% Sodium Chloride Injection, USP, 0.9% (900 mg per 100 mL) (9 mg per mL) 100 mL in a 100 mL freeflex bag, Rx only, Fresenius Kabi USA, LLC ("Fresen

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