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Nephron Sc Inc FDA Recalls
6 recalls on file across drugs, 0 of them Class I and 0 still open. This firm is not matched to a listed company.
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Class I is the FDA's most serious grade: a reasonable probability of serious harm or death.
| Product |
|---|
| Sterile Water for Injection, USP, 30x5 mL Single-Dose Vials, Rx Only, Nephron 4500 12th Street Extension West Columbia, Class IIFeb 23, 2023CGMP Deviations: Potential product carryover. |
| S2 Racepinephrine Inhalation Solution, USP 2.25% Bronchodilator 30x0.5 mL Sterile Unit-of-Use Vials each in a foil pouchClass IIJan 13, 2023Short Fill |
| Asthmanefrin Racepinephrine Inhalation Solution Bronchodilator (racephedrine, USP 11.25), 30x0.5 mL Sterile Vials each iClass IIJan 13, 2023Short Fill |
| Sterile Water for Injection, USP, For Drug Diluent Use Only, 5 mL Single-Dose Vial, packaged in 30 x 5 mL Single-Dose ViClass IIJan 12, 2023CGMP Deviations: potential for trace amounts of product carr |
| 0.9% Sodium Chloride Injection, USP, 100 mL Single-Dose Container bag, Rx Only, Nephron Pharmaceuticals Corporation, 450Class IIJan 12, 2023CGMP Deviations: potential for trace amounts of product carr |
| Ketorolac Tromethamine Injection, USP 60 mg/2 mL (30 mg/mL), packaged in 2 mL single dose vials, Rx Only, Nephron PharmaClass IIAug 10, 2022cGMP Deviations: deviations leading to potential cross-conta |