4e Brands North America Issues Expanded Nationwide Voluntary Recall of Hand Sanitizer Due to Potential Presence of Undeclared Methanol (Wood Alcohol), July 30, 2020

Summary

Company Announcement Date:

July 24, 2020

FDA Publish Date:

July 27, 2020

Product Type:

Drugs

Reason for Announcement:

Undeclared Methanol

Company Name:

4e Brands North America

Brand Name:

Assured, Blumen, Modesa

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:

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/External Link Disclaimer

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 formor 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

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/4e-brands-north-america-issues-expanded-nationwide-voluntary-recall-hand-sanitizer-due-potential?utm_campaign=4e%20Brands%20North%20America%20Issues%20Expanded%20Nationwide%20Voluntary%20Recall%20of%20Hand%20Sanitizer&utm_medium=email&utm_source=Eloqua