85%Confidence
0Views
FDASource
2026-04-09Date
Summary
Chiesi USA's Class II recall for CUROSURF due to sterility concerns affects a critical neonatal respiratory drug, potentially endangering vulnerable patients and damaging the brand's reputation. This could lead to increased scrutiny of Chiesi's manufacturing processes and temporary reliance on competitors' surfactants in neonatal care.
Actionable: Monitor hospital formulary changes for neonatal respiratory drugs as CUROSURF availability is impacted.
AI Confidence: 85%
Data Points
firmChiesi USA, Inc.
classificationClass II
statusOngoing
distributionNationwide within the United States
productCUROSURF (poractant alfa), 240 mg, Intratracheal Suspension, 3L Single-dose-Vial, Rx only, Chiesi USA, Inc, Cary, NC 27518, NDC 10122-510-03.
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