Azurity Pharmaceuticals, Inc.
FDA Regulatory Profile
Summary
- Total Recalls
- 4 (2 Class I)
- 510(k) Clearances
- 0
- Inspections
- 8
- Compliance Actions
- 1
Recent Recalls
| Number | Class | Product | Date |
|---|
| D-0323-2024 | Class I | Zenzedi (Dextroamphetamine Sulfate) CII Tablets, USP, 30 mg, 30-count bottle, Rx only, Mfd. for: Arb | January 4, 2024 |
| D-0213-2024 | Class III | Eprontia (topiramate) oral solution, 25 mg/mL, 473 mL Bottle, Rx only, Manufactured for: Azurity Pha | December 8, 2023 |
| D-0489-2023 | Class II | Testosterone Cypionate Injection, USP, CIII, 200 mg/mL, packaged in: a) 10 mL multiple-dose vials (N | February 15, 2023 |
| D-0003-2022 | Class I | Firvanq (vancomycin hydrochloride for oral solution), Vancomycin 50 mg/mL Kit, Each Kit Includes: 1 | August 24, 2021 |