App Pharmaceuticals Llc
FDA Regulatory Profile
App Pharmaceuticals Llc appears in FDA public data with 2 recalls, 1 510(k) clearance, 2 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-1825-2012, Class II) was initiated on May 20, 2010. Its most recent 510(k) clearance was granted on June 18, 2010.
Summary
- Total Recalls
- 2
- 510(k) Clearances
- 1
- Inspections
- 2
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-1825-2012 | Class II | HEPARIN LOCK FLUSH SOLUTION, USP, 100 USP Units/mL, 1 mL Multiple Dose Vial, plastic vial, vial siz | May 20, 2010 |
| Z-1824-2012 | Class II | HEPARIN LOCK FLUSH SOLUTION, USP, 10 USP Units/mL, 1 mL Multiple Dose Vial, plastic vial, vial size | May 20, 2010 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K092938 | HEPARIN LOCK FLUSH SOLUTION USP, MODELS 504401, 504411, 504505, 505701, 504901, 1710 | June 18, 2010 |