FDA-Drug2026-04-01Class II
CUROSURF (poractant alfa), 240 mg, Intratracheal Suspension, 3L Single-dose-Vial, Rx only, Chiesi USA, Inc, Cary, NC 27518, NDC 10122-510-03.
Chiesi USA, Inc.
Hazard
Lack of Assurance of Sterility
Sold states
Nationwide within the United States
Affected count
7,235 vials
Manufactured in
175 Regency Woods Pl Ste 600, Cary, NC, United States
Products
CUROSURF (poractant alfa), 240 mg, Intratracheal Suspension, 3L Single-dose-Vial, Rx only, Chiesi USA, Inc, Cary, NC 27518, NDC 10122-510-03.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0402-2026Original summary
CUROSURF (poractant alfa), 240 mg, Intratracheal Suspension, 3L Single-dose-Vial, Rx only, Chiesi USA, Inc, Cary, NC 27518, NDC 10122-510-03. Lack of Assurance of Sterility Lot #: 1213748, Exp. Date 09/2026; 1215076, 1215077, Exp. Date 10/26. Distribution: Nationwide within the United States Affected quantity: 7,235 vials
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