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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

Fresenius Sodium Chloride Injection Bags Recalled for Potential Sterility Loss

Agency Publication Date: June 1, 2023
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Summary

Fresenius Medical Care Holdings is recalling 53,424 bags of Sodium Chloride 0.9% Injection, USP (saline), in the 1000 mL size. This recall was initiated because the product was potentially exposed to storage temperatures below the recommended range, which may cause the packaging to leak. No injuries or illnesses have been reported in connection with this issue.

Risk

Leaking packaging can lead to a loss of sterility in the saline solution. Using a non-sterile injectable product poses a serious risk of infection, which can lead to severe health complications or life-threatening conditions for patients.

What You Should Do

  1. The recalled product is Sodium Chloride 0.9% Injection, USP, sold in 1000 mL bags (12 bags per carton) under the Fresenius Medical Care North America brand with NDC 49230-300-10.
  2. Check your inventory for lot numbers 23AU05030 (Expiration 01/13/2024) and 23AU05035 (Expiration 01/15/2024).
  3. Stop using the recalled product. Contact Fresenius Medical Care Holdings, Inc. 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 information or to report any adverse events.

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 0.9% Injection, USP, 1000 mL bags
Variants: 1000 mL, 12 bags per carton, Rx only
Lot Numbers:
23AU05030 (Exp 01/13/2024)
23AU05035 (Exp 01/15/2024)
NDC:
49230-300-10

Recall #: D-0777-2023

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 92403
Status: Resolved
Manufacturer: Fresenius Medical Care Holdings, Inc.
Sold By: medical clinics
Manufactured In: United States
Units Affected: 53,424 bags
Distributed To: South Carolina, North Carolina, Virginia

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.