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Drug FDA Class II Terminated Contamination / non-sterility

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 Published Mar 19, 2025

Risk level

Class II

May cause a temporary or reversible health problem; slight chance of serious harm.

Severity score 55/100

What should you do?

  • Check whether you have this product, using the lot codes, UPCs, and dates listed below.
  • Do not eat, serve, or sell the affected product.
  • Return it to the place of purchase for a refund, or throw it away in a sealed bag so people and animals can’t get to it.
  • Contact Nephron Sterile Compounding Center LLC or your place of purchase with questions, and see the source record below for full details.
Reason for recall

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

Hazards

Lack of Sterility Assurance due to Leakage · primary

Affected products (1)

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

4,190 bottles

Lot codes: NA4008B, NA4005B
Code info: Lot # NA4008B, exp. date 03/03/2025 Lot # NA4005B & NA4005E, exp. date 02/20/2025

Affected areas

Nationwide

Timeline

  1. Initiated
    Feb 10, 2025
  2. Published
    Mar 19, 2025
  3. Terminated
    Aug 14, 2025
Recall number
D-0257-2025
Agency
U.S. Food and Drug Administration
Country
US
Source data (openFDA JSON) About FDA enforcement reports

FDA records come from the openFDA drug enforcement-report dataset — the agency's full weekly enforcement list. Most entries are not issued as consumer press releases, so they won't appear on fda.gov/recalls or in a web search. The source record link above resolves this exact recall by its number.