Luitpold Pharmaceuticals, Inc.
FDA Regulatory Profile
Summary
- Total Recalls
- 2
- 510(k) Clearances
- 2
- Inspections
- 0
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| D-1421-2012 | Class II | Epinephrine Injection, USP, 1:1000 (1 mg/mL), 25 x 1 mL Ampules, For SC and IM Use, For IV and IC Us | April 24, 2012 |
| D-1378-2012 | Class II | CONCENTRATED SODIUM CHLORIDE INJECTION, USP, 23.4% a) 30 mL SINGLE DOSE VIAL, (NDC 0517-2930-25), | March 15, 2011 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K111816 | EQUIMATRIX | September 29, 2011 |
| K990537 | OSTEO-PIN MEMBRANE FIXATION PIN | November 19, 1999 |