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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 Device
Medical Devices

Diasol Acid Concentrate Recalled for Misleading Calcium Concentration Labels

Agency Publication Date: October 23, 2024
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Summary

Diasol, Inc. is recalling 852 gallon bottles of Diasol Acid Concentrate (Catalog Number G100325-10Dex100) due to a labeling error. The concentration of calcium listed on the gallon bottle label is lower than the concentration listed on the external box. No incidents or injuries have been reported to date regarding this discrepancy.

Risk

The inconsistent labels may cause healthcare providers to administer incorrect levels of calcium during dialysis treatments. This could potentially lead to electrolyte imbalances or other medical complications for patients.

What You Should Do

  1. The recalled product is Diasol Acid Concentrate (Catalog Number G100325-10Dex100), identified by Lot Number PHS06011/061722 and UDI code B467100325101004.
  2. Check the labels on both the external box and the individual gallon bottles for any discrepancies in the listed calcium concentration.
  3. Stop using the recalled product immediately.
  4. Contact Diasol, Inc. or your distributor to arrange for the return, replacement, or correction of the affected bottles.
  5. Call the FDA at 1-888-463-6332 (1-888-INFO-FDA) for additional information or 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, replacement, or correction.

Affected Products

Product: Diasol Acid Concentrate (1 Gallon)
Model / REF:
G100325-10Dex100
Lot Numbers:
PHS06011/061722
UDI:
B467100325101004

The gallon label shows a lower Calcium concentration than the box label.

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 95334
Status: Active
Manufacturer: Diasol, Inc
Sold By: Diasol, Inc.
Manufactured In: United States
Units Affected: 852 gallon bottles
Distributed To: Arizona

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.