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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Drug
Medications & Supplements/Prescription Drugs

Nephron Sodium Chloride Injection Recalled for Potential Sterility Breach

Agency Publication Date: March 7, 2025
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Summary

Nephron Sterile Compounding Center LLC has recalled 4,190 bottles of Nephron Sodium Chloride Injection 9%, USP (500 mL), a prescription IV solution. The recall was initiated because there is a potential for leakage at the IV bottle port, which could compromise the sterility of the medicine. Consumers or healthcare facilities with these products should stop using them immediately to avoid the risk of administering a contaminated solution.

Risk

A leak at the IV bottle port creates a path for bacteria or other contaminants to enter the sterile fluid. If contaminated fluid is injected into a patient, it could lead to serious infections or life-threatening systemic illness.

What You Should Do

  1. This recall affects Nephron brand Sodium Chloride Injection 9%, USP, 500 mL Single-Dose IV Bottles (NDC 69374-334-50) produced by a 503B outsourcing facility.
  2. Check the packaging for lot numbers NA4008B (expiration March 3, 2025), NA4005B (expiration February 20, 2025), or NA4005E (expiration February 20, 2025).
  3. Stop using the recalled product. Contact Nephron Sterile Compounding Center LLC or your distributor to arrange for the return of any remaining inventory.
  4. Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) for additional questions regarding this recall.

Your Remedy Options

๐Ÿ“‹Other Action
How to: Stop using the recalled product. Contact the manufacturer or your distributor to arrange return.

Affected Products

Product: Sodium Chloride Injection 9%, USP (500 mL)by Nephron
Variants: Single-Dose IV Bottle, Rx Only, 503B outsourcing facility product
Lot Numbers:
NA4008B (Exp 03/03/2025)
NA4005B (Exp 02/20/2025)
NA4005E (Exp 02/20/2025)
NDC:
69374-334-50

Recall #: D-0257-2025

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 96419
Status: Resolved
Manufacturer: Nephron Sterile Compounding Center LLC
Sold By: Hospitals; Wholesalers; Infusion Centers; Medical Facilities
Manufactured In: United States
Units Affected: 4,190 bottles
Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.