Chiesi USA, Inc.

FDA Regulatory Profile

Summary

Total Recalls
3
510(k) Clearances
0
Inspections
8
Compliance Actions
3

Recent Recalls

NumberClassProductDate
D-0402-2026Class IICUROSURF (poractant alfa), 240 mg, Intratracheal Suspension, 3L Single-dose-Vial, Rx only, Chiesi USMarch 17, 2026
D-1342-2019Class IIZileuton Extended-Release Tablets, 600 mg, 120-count bottles, Rx only, Distributed by: Prasco LaboraMay 31, 2019
D-1341-2019Class IIZYFLO CR (zileuton) extended-release tablets, 600 mg, 120-count bottles, Rx only, Distributed by ChiMay 31, 2019