Nivagen Pharmaceuticals Inc
FDA Regulatory Profile
Nivagen Pharmaceuticals Inc appears in FDA public data with 1 recall, 1 510(k) clearance, 2 FDA inspections, and 0 compliance actions on record. Its most recent recall (D-0001-2025, Class II) was initiated on September 24, 2024. Its most recent 510(k) clearance was granted on December 20, 2013.
Summary
- Total Recalls
- 1
- 510(k) Clearances
- 1
- Inspections
- 2
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| D-0001-2025 | Class II | Atorvastatin Calcium Tablets, USP, 40mg, Rx only, 1000 Tablets per bottle, Manufactured for: Nivagen | September 24, 2024 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K132329 | NIVATOPIC PLUS | December 20, 2013 |