Nephron Sc Inc
FDA Regulatory Profile
Nephron Sc Inc has 7 FDA recalls, 22 inspections, 0 510(k) clearances and 5 compliance actions on record.
- Latest recall
- D-0479-2026 · Class II · Mar 17, 2026
- Latest inspection
- Aug 22, 2025 · VAI
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Summary
Record counts and when each FDA source was last refreshed
| Records | Count | Last refreshed | Source as of | Status |
|---|
| Recalls | 7 | Nov 4, 2026 (checked Nov 8, 2026, unchanged) | File dated Nov 3, 2026 | Current |
|---|
| 510(k) clearances | 0 | Nov 8, 2026 | File dated Nov 2, 2026 | Current |
|---|
| Inspections | 22 | Nov 8, 2026 | Newest record Oct 28, 2026 | Current |
|---|
| Compliance actions | 5 | Nov 2, 2026 | Newest record Oct 29, 2026 | Current |
|---|
Recent Recalls
| Number | Class | Product | Date |
|---|
| D-0479-2026 | Class II | Albuterol Sulfate Inhalation Solution, 0.5%, 25 mg/5 mL (5 mg/mL*), 30x5 mL Sterile Unit-Dose Vials… | Mar 17, 2026 |
| D-0364-2023 | Class II | Sterile Water for Injection, USP, 30x5 mL Single-Dose Vials, Rx Only, Nephron 4500 12th Street… | Feb 23, 2023 |
| D-0175-2023 | Class II | Asthmanefrin Racepinephrine Inhalation Solution Bronchodilator (racephedrine, USP 11.25), 30x0.5 mL… | Jan 13, 2023 |
| D-0176-2023 | Class II | S2 Racepinephrine Inhalation Solution, USP 2.25% Bronchodilator 30x0.5 mL Sterile Unit-of-Use Vials… | Jan 13, 2023 |
| D-0177-2023 | Class II | 0.9% Sodium Chloride Injection, USP, 100 mL Single-Dose Container bag, Rx Only, Nephron… | Jan 12, 2023 |
| D-0178-2023 | Class II | Sterile Water for Injection, USP, For Drug Diluent Use Only, 5 mL Single-Dose Vial, packaged in 30 x… | Jan 12, 2023 |
| D-1354-2022 | Class II | Ketorolac Tromethamine Injection, USP 60 mg/2 mL (30 mg/mL), packaged in 2 mL single dose vials, Rx… | Aug 10, 2022 |
Recent FDA Inspections
| Date | Site | Product | Classification | FEI |
|---|
| Aug 22, 2025 | West Columbia, SC | Drugs | Voluntary Action Indicated (VAI) | 3010892830 |
| Sep 25, 2024 | West Columbia, SC | Drugs | Official Action Indicated (OAI) | 3010892830 |
| Feb 9, 2024 | West Columbia, SC | Drugs | Official Action Indicated (OAI) | 3010892830 |
| Feb 10, 2023 | West Columbia, SC | Drugs | Official Action Indicated (OAI) | 3010892830 |
| Apr 20, 2022 | West Columbia, SC | Drugs | Official Action Indicated (OAI) | 3010892830 |
| Apr 20, 2022 | West Columbia, SC | Drugs | Official Action Indicated (OAI) | 3010892830 |
| Nov 15, 2019 | West Columbia, SC | Drugs | Voluntary Action Indicated (VAI) | 3010892830 |
| Jun 7, 2019 | West Columbia, SC | Drugs | No Action Indicated (NAI) | 3010892830 |
| Nov 14, 2018 | West Columbia, SC | Drugs | Voluntary Action Indicated (VAI) | 3010892830 |
| Jul 17, 2018 | West Columbia, SC | Devices | No Action Indicated (NAI) | 3010892830 |
| Apr 20, 2018 | West Columbia, SC | Drugs | Voluntary Action Indicated (VAI) | 3010892830 |
| Apr 21, 2017 | West Columbia, SC | Drugs | Voluntary Action Indicated (VAI) | 3010892830 |
| Jan 20, 2017 | West Columbia, SC | Drugs | Voluntary Action Indicated (VAI) | 3010892830 |
| Dec 9, 2016 | West Columbia, SC | Drugs | No Action Indicated (NAI) | 3010892830 |
| Jul 6, 2016 | West Columbia, SC | Drugs | No Action Indicated (NAI) | 3010892830 |
| Aug 14, 2015 | West Columbia, SC | Devices | Voluntary Action Indicated (VAI) | 3010892830 |
| Mar 12, 2015 | West Columbia, SC | Drugs | No Action Indicated (NAI) | 3010892830 |
| Nov 13, 2014 | West Columbia, SC | Drugs | No Action Indicated (NAI) | 3010892830 |
| Feb 21, 2014 | West Columbia, SC | Drugs | Voluntary Action Indicated (VAI) | 3010892830 |
| Aug 17, 2012 | West Columbia, SC | Drugs | Voluntary Action Indicated (VAI) | 3010892830 |
NAI means no objectionable conditions or practices were found during the inspection. VAI means objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action. OAI means regulatory and/or administrative actions are recommended.
FDA-Inspected Facilities
| Facility | Location | Inspections | Latest |
|---|
| FEI 3010892830 | West Columbia, SC | 22 | Aug 22, 2025 |