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🏥 FDA: Chiesi USA, Inc. — Class II

healthcareactionableSource: FDA
85%Confidence
0Views
FDASource
2026-04-08Date

Summary

Chiesi USA's Class II recall for CUROSURF due to sterility concerns affects a critical neonatal respiratory drug, potentially creating supply shortages in neonatal intensive care units. This could temporarily benefit competitors with similar surfactant products while Chiesi addresses the manufacturing issues.

Actionable: Identify alternative surfactant suppliers and assess potential short-term market opportunities created by this recall.

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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