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Nephron Pharmaceuticals Corp.

FDA Regulatory Profile

Nephron Pharmaceuticals Corp. has 89 FDA recalls (3 Class I), 2 inspections, 3 510(k) clearances and 0 compliance actions on record.

Latest recall
D-0257-2025 · Class II · Feb 10, 2025
Latest inspection
Dec 2, 2022 · VAI
Latest 510(k)
Feb 9, 2023

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Summary

Record counts and when each FDA source was last refreshed
RecordsCountLast refreshedSource as ofStatus
Recalls89 (3 Class I)Oct 23, 2026Not statedCurrent
510(k) clearances3Oct 4, 2026Not statedCurrent
Inspections2Oct 27, 2026Not statedCurrent
Compliance actions0Oct 23, 2026Not statedCurrent

Recent Recalls

NumberClassProductDate
D-0257-2025Class IISodium Chloride Injection 9%, USP, 500 mL, Single-Dose IV Bottle, Rx Only, nephron, 503B outsourcing…Feb 10, 2025
D-0356-2023Class IINorepinephrine Bitartrate in 0.9% Sodium Chloride Injection, USP, 8 mg/250 mL (32 mcg/mL*), 250 mL…Feb 22, 2023
D-0357-2023Class IINorepinephrine Bitartrate in 0.9% Sodium Chloride Injection, USP, 4 mg/250 mL (16 mcg/mL*), 250 mL…Feb 22, 2023
D-0355-2023Class IIDiltiazem HCl in 0.7% Sodium Chloride Injection, 125 mg/125 mL (1 mg/mL), 125 mL Single-Dose…Feb 22, 2023
D-0359-2023Class IIPhenylephrine HCl Injection, USP, 1 mg/10 mL (100 mcg/mL), 10 mL Single-Dose Vial, packaged in 30 x…Feb 22, 2023
D-0361-2023Class IIPhenylephrine HCl Injection, USP, 0.8 mg/10 mL (80 mcg/mL), 10 mL Single-Dose Vial, packaged in 30 x…Feb 22, 2023
D-0362-2023Class IIPhenylephrine HCl in 0.9% Sodium Chloride Injection, USP, 50 mg/250 mL (200 mcg/mL), 250 mL…Feb 22, 2023
D-0360-2023Class IIPhenylephrine HCl Injection, USP, 0.4 mg/10 mL (40 mcg/mL), 10 mL Single-Dose Vial, packaged in 30 x…Feb 22, 2023
D-0358-2023Class IINorepinephrine Bitartrate in 0.9% Sodium Chloride Injection, USP, 16 mg/250 mL (64 mcg/mL*), 250 mL…Feb 22, 2023
D-0099-2023Class IIRocuronium Bromide Injection, 50 mg/5 mL (10 mg/mL), 5 x 5 mL Pre-Filled Syringe, 6 x 5 syringe…Jan 6, 2023
D-0064-2023Class IIPF-Labetalol HCl Injection, USP 20 mg/4 mL (5 mg/mL) vial, Rx Only, Nephron 503B Outsourcing…Nov 10, 2022
D-0065-2023Class IIPF-Neostigmine Methylsulfate Injection, USP 3 mg/3 mL (1 mg/mL) vial, Rx Only, Nephron 503B…Nov 10, 2022
D-1347-2022Class IIPF-Labetalol HCl Injection, USP, 20 mg/4 mL (5 mg/mL), One 4 mL Unit-Dose Vial, packaged in 30 x 4…Aug 10, 2022
D-1344-2022Class IIPF-Neostigmine Methylsulfate Injection, USP, 3 mg/3 mL (1 mg/mL), One 3 mL Unit-Dose Vial, packaged…Aug 10, 2022
D-1345-2022Class IITrisodium Citrate 0.5% Solution, (0.5%/4L), contains Per Liter: Sodium 140 mmol/L, Chloride 86…Aug 10, 2022
D-1346-2022Class IIPF-0.125% Bupivacaine HCl Injection, USP, 625 mg/500 mL (1.25 mg/mL), 500 mL bag, packaged in 10 x 1…Aug 10, 2022
D-1252-2022Class IIFentanyl Citrate in 0.9% Sodium Chloride Injection, USP, 2500 mcg/250 mL (10 mcg/mL*) bags, packaged…Jun 30, 2022
D-1271-2022Class IINeostigmine Methylsulfate Injection, USP, 4 mg/4 mL (1 mg/mL) syringe, packaged in 5 x 4 mL…Jun 30, 2022
D-1270-2022Class IINeostigmine Methylsulfate Injection, USP, 3 mg/3 mL (1 mg/mL) syringe, packaged in 5 x 3 mL…Jun 30, 2022
D-1266-2022Class IIMorphine Sulfate Injection, USP, 30 mg/30 mL (1 mg/mL) syringe, packaged in 5 x 30 mL Pre-Filled…Jun 30, 2022

Recent FDA Inspections

DateSiteProductClassificationFEI
Dec 2, 2022Murray, KYDrugsVoluntary Action Indicated (VAI)3010247115
Nov 4, 2008Mountain Home, IDDrugsNo Action Indicated (NAI)3004462991

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.

Recent 510(k) Clearances

K-NumberDeviceDate
K223559Nephron Nitrile Powder-Free Nitrile Examination Gloves (Tested For Use With Chemotherapy Drugs)Feb 9, 2023
K113033SODIUM CHLORDE INHALATION SOLUTION, 0.9% USP-3MLJun 19, 2012
K120051SODIUM CHLORIDE INHALATION SOLUTION, 3%, 7%, AND 10%, USP-4MLApr 20, 2012

FDA data resources