Reported Mar 8, 2023 · Terminated

Sterile Water for Injection, USP, 30x5 mL Single-Dose Vials, Rx Only, Nephron 4500 12th Street Extension West Columbia,…

Nephron Sc Inc.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Nephron Sc Inc · 4500 12th Street Ext · West Columbia, SC · 29172-3025

Is this the product you have?

  • 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
Lot codes and dates
    • Lot #: 224011
    • 224021
    • 224022
    • 224023 Exp 12/31/2023
Amount recalled
325,080 vials

Why it was recalled

CGMP Deviations: Potential product carryover.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA drug enforcement) notice

Notice updated Oct 11, 2024 · Data as of Sep 19, 7:23 PM UTC

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