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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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Critical RiskFDA Drug
Medications & Supplements/Topical Products

Volu-Sol, Inc.: Volu-Sol Handrub Sanitizing Solution Recalled Due to Methanol Contamination

Agency Publication Date: September 30, 2020
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Summary

Volu-Sol, Inc. is recalling Volu-Sol Handrub Sanitizing Solution (473 mL / 16 fl oz bottles) because the product lists methanol as an inactive ingredient on the label and is being marketed without required FDA approval. Methanol, or wood alcohol, is a toxic substance that should not be used in hand sanitizers. Consumers should immediately stop using the affected bottles, which were sold to a distributor in California and a hospital system in Utah between 2020 and 2022.

Risk

Methanol exposure can result in nausea, vomiting, headache, blurred vision, permanent blindness, seizures, coma, permanent damage to the nervous system, or death. While anyone using these products on their hands is at risk, young children who accidentally ingest these products and adolescents or adults who drink these products as an alcohol substitute are at highest risk for methanol poisoning.

What You Should Do

  1. Check your hand sanitizer bottles for the name 'Volu-Sol Handrub Sanitizing Solution' in 473 mL (16 fl oz) bottles with NDC 74401-800-16.
  2. Identify if your bottle belongs to one of the following affected lots: WHO100, WHO101 (Exp. 4/2022); or WHO104, WHO105, WHO108, WHO109 (Exp. 05/2022).
  3. Stop using the product immediately if it matches the affected lot numbers or if the label lists 'methanol' as an ingredient.
  4. Contact your healthcare provider or pharmacist for guidance if you have experienced any symptoms related to using this product.
  5. Return any unused product to the place of purchase for a refund and contact Volu-Sol, Inc. for further instructions.
  6. For additional questions, contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls.

Your Remedy Options

๐Ÿ’ฐFull Refund

Healthcare consultation and refund.

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

Affected Products

Product: Volu-Sol Handrub Sanitizing Solution (473 mL/ 16 fl oz)
Model:
NDC 74401-800-16
Lot Numbers:
WHO100 (Exp. 4/2022)
WHO101 (Exp. 4/2022)
WHO104 (Exp. 05/2022)
WHO105 (Exp. 05/2022)
WHO108 (Exp. 05/2022)
WHO109 (Exp. 05/2022)
Date Ranges: Expiration Date 4/2022, Expiration Date 05/2022

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 86428
Status: Resolved
Manufacturer: Volu-Sol, Inc.
Sold By: Hospital system in UT
Manufactured In: United States
Distributed To: California, Utah
Agency Last Updated: October 14, 2020

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.