DMM VISSION, S.A. DE C.V. Issues Voluntary Nationwide Recall of Cleaner Hand Sanitizer 500 mL and 1200 mL Bottles Due to the Possible Presence of Undeclared Methanol (Wood Alcohol)

Summary

Company Announcement

Estado de México, México, DMM VISSION, S.A. de C.V. is voluntarily recalling five lots of Cleaner Hand Sanitizer, 500 mL and 1,200 mL plastic clear bottles with white tops currently in US distribution to the consumer level. This recall is being initiated out of abundance of caution due to detection of methanol (wood alcohol) in hand sanitizer sample manufactured at the same facility.

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 DMM VISSION has not received reports of adverse events related to this recall.

The product is used as a hand sanitizer and are packaged in 500ml and 1200ml plastic clear bottles with white tops. The lot numbers are LC2020407, LC2020408, LC2020502, LC2020504, LC2020507.  This product was first distributed nationwide to wholesale distributors on April 27, 2020 and finished on June 9th, 2020. The recalled products are as follows:

DMM VISSION is notifying its distributors by phone calls, emails and/or mailed letters and is arranging for return of all recalled products. Consumers, distributors, and retailers that have product which is being recalled should stop use or distribution and return to place of purchase.

Consumers with questions regarding this recall can contact DMM VISSION by phone (+52) 5547578351 or email to [email protected] on Monday through Friday from 9 am and 5 pm, CST. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product. Consumers/distributors/retailers that have the above listed lots Cleaner Hand Sanitizer should stop using or distributing the products immediately and mail the products to 700 County Line Rd., Lakewood, NJ, 08701.

Contact Name: José Álvarez
Phone Number: (+52) 5547578351

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.