Grupo Asimex De Mexico Sa De CV Issues Voluntary Nationwide Recall of All Lots of Florence Morris Antiseptic Hand Sanitizer Due to Presence of Methanol (Wood Alcohol) and Sub-Potent Ethanol

Summary

Company Announcement

Grupo Asimex de Mexico SA de CV is voluntarily recalling all lots of FLORANCE MORRIS Antiseptic Hand Sanitizer, 70% Alcohol, packaged in 8 fl oz bottles and 1L bottles to the consumer level. The products have the potential to contain methanol (wood alcohol) and be sub-potent for the ethanol content.

Risk Statement: The use of sub-potent hand sanitizer products can have adverse health consequences related to infections. Ethanol levels below the label claim can result in a lack of efficacy. In addition, methanol has inferior antiseptic properties compared to ethanol. 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 person 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, Grupo Asimex de Mexico SA de CV has not received reports of adverse events related to this recall.

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. The recalled products are as follows:

Product, Sizes and LOT:
FLORANCE MORRIS Antiseptic Hand Sanitizer
8 fl oz, 1 L
LOT CODES: 200520673, 200520674, 200525677, 200601685

The Hand Sanitizer is packaged in an 8 oz. and 1L plastic clear bottles with flip-top caps. Product was distributed in the state of FLORIDA in the United States through one distributor.

Grupo Asimex de Mexico is notifying its distributor by recall letter and consumers via this press release. Grupo Asimex de Mexico is arranging for the return and refund of all recalled products. Consumers/distributors 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 Grupo Asimex de Mexico SA de CV during business hours to the following email: [email protected] Event: Recall

Consumers should contact their physician or healthcare provider if they experienced any problems that may be related to the use of 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.

FDA updates on hand sanitizers consumers should not use