Recall on Hand Sanatizer in the States

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https://www.emergencyemail.org/newsemergency/anmviewer.asp?a=22624&z=63

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FDA warns about harmful hand sanitizer products

(Our product safety information is produced by our editors and some content sourced from information provided by the respective company directly and government regulatory agencies. If this is a recall we encourage you to contact the company directly for complete information.)

The Food and Drug Administration (FDA) has identified products that contain methanol.

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

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

FDA is alerting consumers of Saniderm Products and UVT Inc.'s voluntary recall of Saniderm Advanced Hand Sanitizer. Following FDA’s recommendation, two distributors - Saniderm Products and UVT - agreed to recall Saniderm Advanced Hand Sanitizer packaged in 1-liter plastic bottles and labeled with “Made in Mexico” and “Produced by: Eskbiochem SA de CV.”

  • The UVT hand sanitizer is labeled with lot number 0530 and an expiration date of 04/2022.
  • The Saniderm Products hand sanitizer is labeled with lot number 53131626 and “Manufactured on April/1/20.”

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 (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.

The FDA also recalled the following products:

LIQ-E S.A. de C.V. is voluntarily recalling all lots and all bottle sizes of The OPTIMUS Instant Hand Sanitizer due to the potential presence of methanol (wood alcohol) that were shipped into the United States. The products were manufactured between April 27, 2020 and May 08, 2020.

AAA Cosmetica, S.A. de C.V. is voluntarily recalling all lots of bio aaa Advance Hand Sanitizer currently in US distribution, packaged in 480 mL bottles, to the consumer level. The products are being recalled due to the potential presence of methanol (wood alcohol).

Soluciones Cosmeticas 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).

San Antonio, Texas, 4e Brands North America is voluntarily recalling ten (10) bottle sizes of Hand Sanitizers to the consumer level. The products are being recalled due to the potential presence of methanol (wood alcohol).

ITECH 361 is voluntarily recalling 18,940 bottles of All Clean Hand Sanitizer, Moisturizer and Disinfectant sold in one liter bottles to the consumer level. The products are being recalled due to the potential presence of methanol (wood alcohol).

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