Medications & Supplements/Prescription Drugs

Fresenius Medical Care Renal Therapies Group, LLC: 0.9% Sodium Chloride Injection Recalled for Lack of Sterility Assurance

Agency Publication Date: May 22, 2018

Summary

Fresenius Medical Care North America has recalled 25,356 bags of 0.9% Sodium Chloride Injection (saline), USP, 1000 mL. This recall was initiated because the manufacturer cannot guarantee the sterility of the product. Using a non-sterile injectable medication can lead to serious systemic infections or other life-threatening health complications. This prescription drug was distributed nationwide in 1-liter bags under NDC 49230-0300-10.

Risk

A lack of sterility assurance means the injection may contain microorganisms such as bacteria or fungi. If contaminated fluid is injected directly into the bloodstream, it can cause severe infection, sepsis, or permanent injury.

What You Should Do

Locate the product packaging and check for NDC 49230-0300-10 and Part Number 060-10109.
Verify if your product belongs to Lot # 17LU05005 with an expiration date of 09/18.
Immediately stop using any 1000 mL bags matching these specific lot and part numbers.
Contact your healthcare provider or pharmacist immediately if you have received this injection and are experiencing any unusual symptoms or signs of infection.
Return any unused product to the pharmacy or place of purchase for a refund and contact Fresenius Medical Care Renal Therapies Group, LLC for further instructions.
For additional questions or to report a problem, contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls.

Your Remedy Options

Full Refund

How to: Contact your healthcare provider or pharmacist for guidance. Return any unused product to the pharmacy for a refund

Affected Products

Product: 0.9% Sodium Chloride Injection, USP (1000 mL)

Model:

060-10109

NDC 49230-0300-10

Recall #: D-0827-2018

Lot Numbers:

17LU05005 (Exp. 09/18)

Date Ranges: Expiration Date: 09/18

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 79501

Status: Resolved

Manufacturer: Fresenius Medical Care Renal Therapies Group, LLC

Manufactured In: United States

Units Affected: 25,356 1 liter bags

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 · 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.

Summary

What You Should Do

Locate the product packaging and check for NDC 49230-0300-10 and Part Number 060-10109.

Verify if your product belongs to Lot # 17LU05005 with an expiration date of 09/18.

Immediately stop using any 1000 mL bags matching these specific lot and part numbers.

Contact your healthcare provider or pharmacist immediately if you have received this injection and are experiencing any unusual symptoms or signs of infection.

Return any unused product to the pharmacy or place of purchase for a refund and contact Fresenius Medical Care Renal Therapies Group, LLC for further instructions.

For additional questions or to report a problem, contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls.