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  4. 4e Brands North America Issues Expanded Nationwide Voluntary Recall of Hand Sanitizer Due to Potential Presence of Undeclared Methanol (Wood Alcohol)
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COMPANY ANNOUNCEMENT

4e Brands North America Issues Expanded Nationwide Voluntary Recall of Hand Sanitizer Due to Potential Presence of Undeclared Methanol (Wood Alcohol)

When a company announces a recall, market withdrawal, or safety alert, the FDA posts the company's announcement as a public service. FDA does not endorse either the product or the company.

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Summary

Company Announcement Date:
FDA Publish Date:
Product Type:
Drugs
Reason for Announcement:
Recall Reason Description
Undeclared Methanol
Company Name:
4e Brands North America
Brand Name:
Brand Name(s)
Assured, Blumen, Modesa
Product Description:
Product Description
Hand Sanitizer

Company Announcement

San Antonio, Texas, 4e Brands North America is voluntarily recalling all lots of Hand Sanitizer brands to the consumer level. These products are being recalled due to the potential presence of methanol (wood alcohol).

Risk Statement: Substantial methanol exposure could result in nausea, vomiting, headache, blurred vision, permanent blindness, seizures, coma, permanent damage to the nervous system or death. Although all persons using these products on their hands are at risk, young children who accidentally ingest these products and adolescents and adults who drink these products as an alcohol (ethanol) substitute, are most at risk for methanol poisoning.

RECALLED PRODUCTS

These products are used as hand sanitizers and marketed to help decrease bacteria on the skin when soap and water are not available. This recall now includes all product manufactured by 4e within expiration, regardless of the size, UPC, or lot number. The recalled products are as follows:

Product(s)

Country of Origin

Product Size

Product Label

UPC Code 

ASSURED ALOE HAND SANITIZER Mexico 8FL OZ/ 236 ML See Product Image Below 639277490704
ASSURED CLEAR HAND SANITIZER Mexico 8FL OZ/ 236ML See Product Image Below 639277490698
ASSURED ALOE HAND SANITIZER Mexico 10FL OZ See Product Image Below 639277490704
ASSURED CLEAR HAND SANITIZER Mexico 10FL OZ See Product Image Below 639277490698
BLUMEN ADVANCED CLEAR HAND SANITIZER Mexico 2 FL OZ See Product Image Below 814266023716
BLUMEN ALOE ADVANCED HAND SANITIZER Mexico 3.4FL OZ See Product Image Below 814266023587
BLUMEN ADVANCED HAND SANITIZER Mexico 3.4FL OZ See Product Image Below 814266023594
BLUMEN ADVANCED HAND SANITIZER Mexico 7.5FLOZ / 221ML See Product Image Below 814266023624
BLUMEN ADVANCED CLEAR HAND SANITIZER Mexico 7.5 FL OZ See Product Image Below 814266023624
BLUMEN ADVANCED HAND SANITIZER Mexico 7.5FLOZ / 221ML See Product Image Below 814266023624
BLUMEN ADVANCED HAND SANITIZER Mexico 15.2 FL OZ See Product Image Below 814266023921
BLUMEN ADVANCED CLEAR HAND SANITIZER Mexico 17 FL OZ See Product Image Below 814266024096
BLUMEN ADVANCED CLEAR HAND SANITIZER Mexico 17 FL OZ See Product Image Below 814266024096
BLUMEN CLEAR HAND SANITIZER Mexico 18 FL OZ See Product Image Below 814266023914
BLUMEN CLEAR TEA TREE HAND SANITIZER Mexico 18 FL OZ See Product Image Below 814266024089
BLUMEN ADVANCED HAND SANITIZER Mexico 33.8 FL OZ See Product Image Below 814266023693
BLUMEN ADVANCED CLEAR HAND SANITIZER Mexico 33.8 FL OZ See Product Image Below 814266023693
BLUMEN ADVANCED CLEAR HAND SANITIZER Mexico 33.8 FL OZ See Product Image Below 814266023693
BLUMEN ADVANCED CLEAR TEA TREE HAND SANITIZER Mexico 33.8 FL OZ See Product Image Below 814266023747
BLUMEN ADVANCED CLEAR HAND SANITIZER Mexico 70 FL OZ See Product Image Below 814266023679
BLUMEN ADVANCED CLEAR HAND SANITIZER Mexico 1.05 GAL See Product Image Below 814266023686
MODESA CLEAR GEL ANTIBACTERIAL Mexico 33.8 FL OZ See Product Image Below 032251499357

The affected Hand Sanitizers are packaged in clear plastic bottles with variation of tops, including blue, white, or clear pumps or caps. The product labels are displayed in the chart above and also included in this press release under images.

The product was distributed nationwide in the United States through retailers and distributors.

4e Brands North America is notifying its distributors and retailers by recall letter and consumers via this press release. 4e Brands North America is arranging for the return and refund of all recalled products.

Consumers/distributors/retailers that have the product subject to this recall should stop using/distributing/ selling the hand sanitizer and return it to the place of purchase.

Consumers with questions regarding this recall can contact 4e Brands North America LLC at:

Toll Free: 888-843-0254 Mon-Fri 8am – 8 PM Eastern

FAX: 888-214-7430
Event: 8797
Website: https://www.blumensanitizerrecall.expertinquiry.com/

Consumers should contact their physician or healthcare provider if they experienced any problems that may be related to taking or using this product.

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

  • Complete and submit the report Online
  • Regular Mail or Fax: Download form or call 1- 800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.

Link to Initial Release

Link to CDER Release

 


Company Contact Information

Consumers:
4e Brands North America
888-843-0254

Product Photos

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