FDA advises consumers not to use hand sanitizer products manufactured by Eskbiochem

[6/19/2020] FDA advises consumers not to use any hand sanitizer manufactured by
Eskbiochem SA de CV in Mexico, due to the potential presence of methanol (wood
alcohol), a substance that can be toxic when absorbed through the skin or ingested.
FDA has identified the following products manufactured by Eskbiochem:

• All-Clean Hand Sanitizer (NDC: 74589-002-01)
• Esk Biochem Hand Sanitizer (NDC: 74589-007-01)
• CleanCare NoGerm Advanced Hand Sanitizer 75% Alcohol (NDC: 74589-008-
04)
• Lavar 70 Gel Hand Sanitizer (NDC: 74589-006-01)
• The Good Gel Antibacterial Gel Hand Sanitizer (NDC: 74589-010-10)
• CleanCare NoGerm Advanced Hand Sanitizer 80% Alcohol (NDC: 74589-005-
03)
• CleanCare NoGerm Advanced Hand Sanitizer 75% Alcohol (NDC: 74589-009-
01)
• CleanCare NoGerm Advanced Hand Sanitizer 80% Alcohol (NDC: 74589-003-
01)
• Saniderm Advanced Hand Sanitizer (NDC: 74589-001-01)

FDA tested samples of Lavar Gel and CleanCare No Germ. Lavar Gel contains 81
percent (v/v) methanol and no ethyl alcohol, and CleanCare No Germ contains 28
percent (v/v) methanol. Methanol is not an acceptable ingredient for hand sanitizers
and should not be used due to its toxic effects.

Consumers who have been exposed to hand sanitizer containing methanol should seek
immediate treatment, which is critical for potential reversal of toxic effects of
methanol poisoning. 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.

On June 17, 2020, FDA contacted Eskbiochem to recommend the company remove its
hand sanitizer products from the market due to the risks associated with methanol
poisoning. To date, the company has not taken action to remove these potentially
dangerous products from the market. Therefore, FDA recommends consumers stop
using these hand sanitizers and dispose of them immediately in appropriate hazardous
waste containers. Do not flush or pour these products down the drain.

FDA reminds consumers to wash their hands often with soap and water for at least 20
seconds, especially after going to the bathroom; before eating; and after coughing,
sneezing, or blowing one’s nose. If soap and water are not readily available, the
Centers for Disease Control and Prevention

(https://www.cdc.gov/handwashing/show-me-the-science-hand-sanitizer.html)

(CDC) recommend consumers use an alcohol-based hand sanitizer that contains at
least 60 percent ethanol.

FDA remains vigilant and will continue to take action when quality issues arise with
hand sanitizers. Additionally, the agency is concerned with false and misleading claims
for hand sanitizers, for example that they can provide prolonged protection such as
24-hours against viruses including COVID-19, since there is no evidence to support
these claims.

To date, FDA is not aware of any reports of adverse events associated with these hand
sanitizer products. FDA encourages health care professionals, consumers and patients
to report adverse events or quality problems experienced with the use of hand
sanitizers to FDA’s MedWatch Adverse Event Reporting (/safety/medwatch-fdasafety-information-and-adverse-event-reporting-program) program:

• Complete and submit the report online
(https://www.accessdata.fda.gov/scripts/medwatch/index.cfm); or

• Download and complete the form (/media/85598/download), then submit it via
fax at 1-800-FDA-0178