Drug company (FDA labeler)

Nephron Pharmaceuticals Corporation

NDC labeler code: 0487

What is a labeler?

The company whose name is on the package and in the FDA’s National Drug Code (NDC) Directory. It may make the medicine itself or sell medicine made by another company. The first part of every NDC code identifies the labeler.

Official FDA data only

Products, approvals and recalls come from the FDA (NDC Directory, Drugs@FDA, enforcement reports). Recalls are linked to this company by the NDC labeler code on the recalled product.

Questions about your medicine: ask your doctor or pharmacist. In an emergency, call 911.

At a glance

7Prescription medicines

11Products (NDC)

9FDA applications

12Recalls

Prescription medicines

Albuterol sulfateVentolin HFA, Albuterol Sulate HFA, Proair Respiclick · 4 products
BudesonidePulmicort Flexhaler, Pulmicort Respules, Uceris · 2 products
Sodium chlorideBacteriostatic Sodium Chloride · 1 product
Ipratropium bromideAtrovent HFA · 1 product
Ipratropium bromide and albuterol sulfateCombivent Respimat · 1 product
WaterSterile Water, Bacteriostatic Water, Insulin Diluting Medium for Garzulys · 1 product
Ketorolac tromethamineAcuvail, Sprix, Ketrolac Tromethamine · 1 product

FDA applications for these products

ANDA: Abbreviated New Drug Application: how a generic version is approved.

Approved	Application	Medicine	Sponsor
February 10, 2021	ANDA211222	Water STERILE WATER FOR INJECTION	Nephron
August 20, 2020	ANDA211445	Ketorolac tromethamine KETOROLAC TROMETHAMINE	Nephron
April 23, 2020	ANDA211968	Sodium chloride SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	Nephron
March 30, 2009	ANDA078202	Budesonide BUDESONIDE	Nephron
December 31, 2007	ANDA076749	Ipratropium bromide and albuterol sulfate ALBUTEROL SULFATE AND IPRATROPIUM BROMIDE, ALBUTEROL SULFATE; IPRATROPIUM BROMIDE	Nephron
June 28, 2004	ANDA076355	Albuterol sulfate ALBUTEROL SULFATE	Nephron
September 27, 2001	ANDA075562	Ipratropium bromide IPRATROPIUM BROMIDE	Nephron
June 26, 2001	ANDA075664	Albuterol sulfate ALBUTEROL SULFATE	Nephron
September 17, 1997	ANDA074880	Albuterol sulfate ALBUTEROL SULFATE	Nephron

The sponsor is the company that holds the FDA application; it can differ from the labeler.

Recall timeline

2023

February 23, 2023 · Class II · Terminated · D-0364-2023 · Water

CGMP Deviations: Potential product carryover.

Sterile Water for Injection, USP, 30x5 mL Single-Dose Vials, Rx Only, Nephron 4500 12th Street Extension West Columbia, SC 29172, NDC 0487-6105-01
January 12, 2023 · Class II · Terminated · D-0177-2023 · Sodium chloride

CGMP Deviations: potential for trace amounts of product carryover.

0.9% Sodium Chloride Injection, USP, 100 mL Single-Dose Container bag, Rx Only, Nephron Pharmaceuticals Corporation, 4500 12th St. Extension, W. Columbia, SC 29172, NDC: 0487-4301-10, UPC 3 04874 30110 3.
January 12, 2023 · Class II · Terminated · D-0178-2023 · Water

CGMP Deviations: potential for trace amounts of product carryover.

Sterile Water for Injection, USP, For Drug Diluent Use Only, 5 mL Single-Dose Vial, packaged in 30 x 5 mL Single-Dose Vials per carton, Rx Only, Nephron Pharmaceuticals Corporation, 4500 12th Street Extension, W. Columbi

2022

August 10, 2022 · Class II · Terminated · D-1354-2022 · Ketorolac tromethamine

cGMP Deviations: deviations leading to potential cross-contamination.

Ketorolac Tromethamine Injection, USP 60 mg/2 mL (30 mg/mL), packaged in 2 mL single dose vials, Rx Only, Nephron Pharmaceutical Corporation 4500 12th Street Extension West Columbia, SV 29172, NDC 0487-6232-01
April 13, 2022 · Class II · Terminated · D-1040-2022 · Ipratropium bromide

cGMP deviations: Temperature abuse

Ipratropium Bromide Inhalation Solution, 0.02%, 0.5 mg/2.5 mL, packaged in 25-count box (25 x 2.5 mL sterile unit-dose vials), Rx only, MFG: Nephron Pharma, NDC 0487-9801-25
April 13, 2022 · Class II · Terminated · D-1018-2022 · Albuterol sulfate

cGMP deviations: Temperature abuse

Albuterol Sulfate Inhalation Solution, 0.021%, 0.63 mg/3mL, packaged in 30 x 3 mL Sterile Unit-Dose Vials, Rx only, MFG: Nephron Pharma, NDC 0487-0301-01
April 13, 2022 · Class III · Terminated · D-1021-2022 · Ipratropium bromide and albuterol sulfate

cGMP deviations: Temperature abuse

Ipratropium Bromide 0.5 mg and Albuterol Sulfate 3 mg Inhalation Solution 3mL vial, packaged in a) 30-count (NDC 0487-0201-03), b) 60-count (NDC 0487-0201-60), Rx only, MFG: Nephron Pharma
April 13, 2022 · Class II · Terminated · D-1020-2022 · Albuterol sulfate

cGMP deviations: Temperature abuse

Albuterol Sulfate Inhalation Solution 0.083%, 2.5 mg/3mL, packaged in 25 X 3mL unit-dose vials, Rx only, MFG by: Nephron Pharma, NDC 0487-9501-25
April 13, 2022 · Class II · Terminated · D-1019-2022 · Albuterol sulfate

cGMP deviations: Temperature abuse

Albuterol Sulfate Inhalation Solution 0.083%, 2.5 mg/3mL, packaged in 5 x 3 mL unit-dose vials, Rx only, Manufactured by: Nephron Pharma, NDC 0487-9501-03

2015

August 21, 2015 · Class II · Terminated · D-0010-2016 · Ipratropium bromide and albuterol sulfate

Lack of Assurance of Sterility; potential exposure to non-sterile lubricant during the filling process

Ipratropium Bromide 0.5 mg and Albuterol Sulfate 3 mg Inhalation Solution, packaged in 30x3 mL Sterile Unit-Dose Vials, a) 30 count (NDC 0487-0201-03) and b) 60 count (NDC 0487-0201-60) vials per carton, Rx only, Nephron

2013

October 2, 2013 · Class II · Terminated · D-66462-001 · Albuterol sulfate

Lack of Assurance of Sterility: Nephron Pharmaceuticals Corporation conducted a routine periodic aseptic process simulation and discovered bacterial growth in a number of media fill vials, exceeding the allowable limit.

Albuterol Sulfate Inhalation Solution, 0.083% 2.5 mg/3 mL for Oral Inhalation Only, Rx Only, 25 x 3 mL Sterile Unit-Dose Vials per carton, Manufactured By: Nephron Pharmaceuticals Corporation, Orlando, FL 32811, NDC 0487

2011

June 22, 2011 · Class II · Terminated · D-1446-2012 · Albuterol sulfate

Lack of Assurance of Sterility

Albuterol Sulfate Inhalation Solution, 0.083%, 2.5 mg/3 mL Sterile Unit-Dose Vials, 60-count (60 x 3 mL Sterile Unit-Dose Vials) per carton, Rx only, Manufactured by: nephron pharmaceuticals corporation, Orlando, FL 3281

What do the recall classes mean?

Class I: The most serious type: there is a reasonable chance that using the product will cause serious health problems or death.
Class II: Using the product may cause temporary or medically reversible health problems, or the chance of serious problems is remote.
Class III: Using the product is not likely to cause health problems (for example a labeling or packaging issue).

Sources

NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026

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