Novartis Pharmaceuticals Corporation
FDA Regulatory Profile
Summary
- Total Recalls
- 6 (1 Class I)
- 510(k) Clearances
- 0
- Inspections
- 39
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| D-0144-2024 | Class I | SANDIMMUNE Oral Solution (cyclosporine oral solution, USP) 100 mg/mL, 50 mL bottle, Rx Only, Manufac | November 22, 2023 |
| D-1543-2022 | Class II | Neoral soft gelatin capsules (cyclosporine capsules, USP) Modified, 25 mg, Rx Only, 30 Soft Gelatin | September 16, 2022 |
| D-0983-2022 | Class III | Xiidra (lifitegrast ophthalmic solution) 5%, packaged in a) 60 Single-Use Containers: 12 pouches x 5 | May 10, 2022 |
| D-0985-2022 | Class III | Xiidra (lifitegrast ophthalmic solution) 5% PROFESSIONAL SAMPLE, packaged in a) 5 single-use contain | May 10, 2022 |
| D-0982-2022 | Class III | Xiidra (lifitegrast ophthalmic solution), packaged in a) 60 Single-Use Containers: 12 pouches x 5 si | May 10, 2022 |
| D-0984-2022 | Class III | Xiidra (lifitegrast ophthalmic solution) 5% PROFESSIONAL SAMPLE, packaged in a) 5 single-use contain | May 10, 2022 |