FDAFDA · Food and drugs·Recall number D-0257-2025
Sodium Chloride Injection 9%, USP, 500 mL, Single-Dose IV Bottle, Rx Only, nephron, 503B outsourcing facility, West Columbia, SC 29172, NDC: 69374-334-50
Published March 19, 2025 · Recall initiated: February 10, 2025
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Lack of Assurance of Sterility: There is a potential for leakage at the IV bottle port.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Nephron Sterile Compounding Center LLC
- Distributor
- US Nationwide.
- Lot
- Lot # NA4008B, exp. date 03/03/2025 Lot # NA4005B & NA4005E, exp. date 02/20/2025
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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