FDA-Drug2025-03-19Class II

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

Nephron Sterile Compounding Center LLC
Hazard

Lack of Assurance of Sterility: There is a potential for leakage at the IV bottle port.

Sold states
US Nationwide.
Affected count
4,190 bottles
Manufactured in
4500 12th Street Ext, West Columbia, SC, United States
Products
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

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0257-2025

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