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FDA - Food and Drug Administration

07/14/2020 | Press release | Distributed by Public on 07/14/2020 17:06

Bersih

COMPANY ANNOUNCEMENT

Soluciones Cosméticas Issues Voluntary Nationwide Recall of Bersih Hand Sanitizer Gel Due to the 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:July 14, 2020FDA Publish Date:July 14, 2020Product Type:Drugs Reason for Announcement:
Recall Reason Description
Potential Methanol Contamination
Company Name:Soluciones CosmeticasBrand Name:
Brand Name(s)
Bersih
Product Description:
Product Description
Hand Sanitizer Gel

Company Announcement

Soluciones Cosméticas is voluntarily recalling all lots of Bersih Hand Sanitizer Gel Fragrance Free sold in 16.9 ounce bottles to the consumer level. The products are being recalled due to the potential presence of methanol (wood alcohol).

Risk Statement: Substantial methanol exposure can 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 accidently ingest these products and adolescents and adults who drink these products as an alcohol (ethanol) substitute, are most at risk for methanol poisoning. To date Soluciones Cosméticas has not received reports of adverse events related to this recall.

The product is used as a hand sanitizer and is packaged in 16.9 ounce plastic clear bottles with blue tops with UPC Code 816822026667. The lot numbers range from 0106K01 to 0148K01. This product was distributed nationwide to wholesale distributors and retailers.

Soluciones Cosméticas is notifying its distributors by voluntary recall letter and consumers via this press release. Consumers that have the product subject to this recall should stop using and either contact Soluciones Cosméticas per the below for disposal instructions or return it to the place of purchase.

Consumers with questions regarding this recall can contact Soluciones Cosméticas at 866-912-8410 Monday through Friday 8am to 5pm Eastern Time or by email at [email protected] Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to 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.

Company Contact Information

Consumers:Soluciones Cosméticas 866-912-8410 [email protected]
Media:Ignacio Puerto +52-55-999-163-5838 [email protected]

Product Photos