Chiesi Usa, Inc.: Curosurf (poractant Alfa), 240 Mg, Intratracheal Suspension, 3l Single-dose-vial

Recalling firm
Chiesi USA, Inc.
Product
CUROSURF (poractant alfa), 240 mg, Intratracheal Suspension, 3L Single-dose-Vial, Rx only, Chiesi USA, Inc, Cary, NC 27518, NDC 10122-510-03.
Reason
Lack of Assurance of Sterility
Classification
Class II
Category
drug recall
Country
United States
Agency
U.S. Food and Drug Administration
Recall date
2026-03-17
Status
Ongoing
Areas affected
AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, ...
Distribution
Nationwide within the United States

Official recall notice from U.S. Food and Drug Administration

Recall details on Nibble Recalls: https://trynibble.app/recalls/83e81ca4-aa41-4cf4-8766-ba90ce9a6aae