The Ritedose Corporation
FDA Regulatory Profile
Summary
- Total Recalls
- 2
- 510(k) Clearances
- 1
- Inspections
- 12
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| D-0946-2023 | Class II | Cromolyn Sodium Oral Solution (Concentrate) 100 mg/5 mL 96 Plastic Ampules per carton, Rx Only, For | July 21, 2023 |
| D-0745-2022 | Class III | 23.4% Sodium Chloride Injection, 120 mEq per 30 mL (4 mEq/mL), 50 mL prefilled syring, Rx Only, RITE | April 1, 2022 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K210126 | Sodium Chloride Inhalation Solutions, 3%, 3.5%, 7% and 10% | December 3, 2021 |