IntegraDose Compounding Services LLC
FDA Regulatory Profile
Summary
- Total Recalls
- 8 (1 Class I)
- 510(k) Clearances
- 0
- Inspections
- 4
- Compliance Actions
- 1
Recent Recalls
| Number | Class | Product | Date |
|---|
| D-0593-2026 | Class II | Vasopressin 2 Units/2 mL in 0.9% Sodium Chloride, syringe, IntegraDose Compounding Services, LLC. 36 | May 18, 2026 |
| D-0548-2026 | Class II | fentaNYL Citrate, Sterile CADD for Injection, 2,2500 mcg/50mL in Sterile Water, IntegraDose Compound | May 12, 2026 |
| D-0015-2026 | Class I | Oxytocin 30 Units/500 mL in 0.9% Sodium Chloride for intravenous use, Rx only, IntegraDose Compoundi | September 16, 2025 |
| D-0432-2024 | Class II | fentaNYL Citrate 2,500 mcg/50mL in Sterile Water, 50 mL CADD for Injection, IntegraDose Compounding | March 22, 2024 |
| D-0325-2024 | Class II | Vasopressin 2 Units/2 mL in 0.9% Sodium Chloride Sterile Syringe for Injection, Concentration: 1 Uni | January 22, 2024 |
| D-0258-2024 | Class II | Vasopressin 2 Unit/2 mL in 0.9% Sodium Chloride, 2 mL per syringe, Rx Only, 719 Kasota Ave SE, Minne | January 12, 2024 |
| D-0897-2021 | Class II | ceFAZolin 3 G in 0.9% Sodium Chloride, 115 mL Bag for Injection, Sterile Product, IntegraDose Compou | September 17, 2021 |
| D-0896-2021 | Class II | ceFAZolin, 2 G/20 mL in Sterile Water, 20 mL Sterile Syringe for Injection, IntegraDose Compounding | September 17, 2021 |