Sodium Chloride Injection 9% recalled over sterility concerns
- Recall date
- February 10, 2025
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Official notice title
- Nephron Sterile Compounding Center LLC recalls Sodium Chloride Injection 9%, USP, 500 mL, Single-Dose IV Bottle, Rx Only, nephron, 503B outsourcing facility, West Col…
- Recall number
- D-0257-2025
- FDA classification
- Class II
- Brand / firm
- Nephron Sterile Compounding Center LLC
- Sold / distributed
- US Nationwide.
Why it was recalled
Lack of Assurance of Sterility: There is a potential for leakage at the IV bottle port.
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
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
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