Nephron Pharmaceuticals Corp.
FDA Regulatory Profile
Summary
- Total Recalls
- 10 (3 Class I)
- 510(k) Clearances
- 2
- Inspections
- 2
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-2053-2016 | Class II | Sodium Chloride Inhalation Solution, USP 3%, 60 x 4 mL Sterile Unit-Dose Vials per carton, Rx Only, | November 16, 2015 |
| Z-2054-2016 | Class II | Sodium Chloride Inhalation Solution, USP 7%, 60 x 4 mL Sterile Unit-Dose Vials, Rx Only, NDC 0487-90 | November 16, 2015 |
| D-0010-2016 | Class II | Ipratropium Bromide 0.5 mg and Albuterol Sulfate 3 mg Inhalation Solution, packaged in 30x3 mL Steri | August 21, 2015 |
| D-0388-2016 | Class II | Asthmanefrin Racepinephrine Inhalation Solution Bronchodilator, Starter Kit (Racepinephrine 11.25 mg | August 21, 2015 |
| D-0389-2016 | Class II | Asthmanefrin Racepinephrine Inhalation Solution Bronchodilator Refills (Racepinephrine USP 11.25 mg | August 21, 2015 |
| D-66462-001 | Class II | Albuterol Sulfate Inhalation Solution, 0.083% 2.5 mg/3 mL for Oral Inhalation Only, Rx Only, 25 x 3 | October 2, 2013 |
| Z-1373-2013 | Class I | EZ Breathe Medication Cup. For the delivery of liquid medications for respiratory usage. | April 30, 2013 |
| Z-1372-2013 | Class I | AsthmaNefrin Starter Kit contains ten (10) AsthmaNefrin vials and one (1) EZ Breathe Atomizer. Fo | April 30, 2013 |
| Z-1371-2013 | Class I | EZ Breathe Atomizer Model # EZ-100. For the delivery of liquid medications for respiratory usage | April 30, 2013 |
| D-1446-2012 | Class II | Albuterol Sulfate Inhalation Solution, 0.083%, 2.5 mg/3 mL Sterile Unit-Dose Vials, 60-count (60 x 3 | June 22, 2011 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K113033 | SODIUM CHLORDE INHALATION SOLUTION, 0.9% USP-3ML | June 19, 2012 |
| K120051 | SODIUM CHLORIDE INHALATION SOLUTION, 3%, 7%, AND 10%, USP-4ML | April 20, 2012 |