West Columbia, SC, United States
Nephron Sc Inc recalls
5 recalls recorded since 2018, most recently on 17 March 2026. 1 is listed as ongoing. Status and classification are as published by the FDA.
Recalls5
Ongoing (FDA)1
Terminated or completed4
Class I (FDA)0
Ongoing Class II Drugs
- Recall started
- 17 March 2026
- Reason
- Labelling: Illegible label
- Distribution
- Nationwide within the United States
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0479-2026
- Albuterol Sulfate Inhalation Solution, 0.5%, 25 mg/5 mL (5 mg/mL*), 30x5 mL Sterile Unit-Dose Vials, Rx only, nephron 503B Outsourcing facility, 4600 12th Street Extension, West Columbia, SC 29172, NDC 69374-330-05.
Terminated Class II Drugs
- Recall started
- 23 February 2023
- Terminated
- 11 October 2024
- Reason
- CGMP Deviations: Potential product carryover.
- Distribution
- United States
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0364-2023
- 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
Terminated Class II Drugs
- Recall started
- 13 January 2023
- Terminated
- 11 October 2024
- Reason
- Short Fill
- Distribution
- Nationwide within the United States including Puerto Rico. Guatamala
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- D-0176-2023, D-0175-2023
- S2 Racepinephrine Inhalation Solution, USP 2.25% Bronchodilator 30x0.5 mL Sterile Unit-of-Use Vials each in a foil pouch, Manufactured By: Nephron West Columbia, SC 29172, NDC 0487-5901-99 UPC 3 04875 90199 9
- Asthmanefrin Racepinephrine Inhalation Solution Bronchodilator (racephedrine, USP 11.25), 30x0.5 mL Sterile Vials each in a foil pouch, NDC 0487-2784-01 UPC 3 04872 78401 4
Terminated Class II Drugs
- Recall started
- 12 January 2023
- Terminated
- 11 October 2024
- Reason
- CGMP Deviations: potential for trace amounts of product carryover.
- Distribution
- Nationwide in the USA
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- D-0177-2023, D-0178-2023
- 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.
- 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
Terminated Class II Drugs
- Recall started
- 10 August 2022
- Terminated
- 24 September 2024
- Reason
- cGMP Deviations: deviations leading to potential cross-contamination.
- Distribution
- USA Nationwide
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-1354-2022
- 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
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.