IntegraDose Compounding Services LLC

FDA Regulatory Profile

Summary

Total Recalls
6 (1 Class I)
510(k) Clearances
0
Inspections
2
Compliance Actions
1

Recent Recalls

NumberClassProductDate
D-0015-2026Class IOxytocin 30 Units/500 mL in 0.9% Sodium Chloride for intravenous use, Rx only, IntegraDose CompoundiSeptember 16, 2025
D-0432-2024Class IIfentaNYL Citrate 2,500 mcg/50mL in Sterile Water, 50 mL CADD for Injection, IntegraDose Compounding March 22, 2024
D-0325-2024Class IIVasopressin 2 Units/2 mL in 0.9% Sodium Chloride Sterile Syringe for Injection, Concentration: 1 UniJanuary 22, 2024
D-0258-2024Class IIVasopressin 2 Unit/2 mL in 0.9% Sodium Chloride, 2 mL per syringe, Rx Only, 719 Kasota Ave SE, MinneJanuary 12, 2024
D-0896-2021Class IIceFAZolin, 2 G/20 mL in Sterile Water, 20 mL Sterile Syringe for Injection, IntegraDose Compounding September 17, 2021
D-0897-2021Class IIceFAZolin 3 G in 0.9% Sodium Chloride, 115 mL Bag for Injection, Sterile Product, IntegraDose CompouSeptember 17, 2021