85%Confidence
0Views
FDASource
2026-04-11Date
Summary
Chiesi USA's Class II recall for CUROSURF due to sterility concerns impacts a critical neonatal respiratory drug, risking patient safety and hospital trust. This could lead to temporary shortages and increased scrutiny on Chiesi's manufacturing practices.
Actionable: Monitor hospital inventories of CUROSURF and prepare for potential shifts to alternative surfactants.
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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