WhichRecall
Class IIReported 2025-03-19

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

Recalled by Nephron Sterile Compounding Center LLC

Reason for Recall

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

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Recall Number
D-0257-2025
Classification
Class II
Status
Terminated
Category
drug
Initiated
2025-02-10
Reported
2025-03-19
Distribution
US Nationwide.
Code Info
Lot # NA4008B, exp. date 03/03/2025 Lot # NA4005B & NA4005E, exp. date 02/20/2025
Source: openFDA enforcement report. WhichRecall is not affiliated with the FDA. See our disclaimer.
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