XELLIA PHARMACEUTICALS USA, LLC

FDA Regulatory Profile

Summary

Total Recalls
2
510(k) Clearances
0
Inspections
5
Compliance Actions
1

Recent Recalls

NumberClassProductDate
D-0756-2021Class IIMicafungin for Injection, 50 mg/vial, Single-Dose Vial, Sterile, Rx Only, For Intravenous Infusion OAugust 6, 2021
D-0757-2021Class IIMicafungin for Injection, 100 mg/vial, Single-Dose Vial, Sterile, Rx Only, For Intravenous Infusion August 6, 2021