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Regulatory Authorities Recall Alcohol Based Hand Sanitizers Containing Methanol


Nsikak
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The National Agency for Food and Drug Administration and Control (NAFDAC)  has received information from US FDA of the  recall of all alcohol- basedhand sanitizer products that are labelled to contain ethanol (also known as ethyl alcohol) but that have tested positive for methanol.

In a another notification,Rwanda Food and Drugs Authority (RFDA) has also banned the use of ‘99% Methanol Alcohol’ hand sanitizer, packed by KVM Co. Ltd.

Methanol, or wood alcohol, is a substance that can be toxic when absorbed through the skin or ingested and can be life-threatening when ingested.

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 for methanol poisoning, young children who accidently ingest these products and adolescents and adults who drink these products as an alcohol (ethanol) substitute, are most at risk.

Methanol is not an acceptable ingredient for hand sanitizers and must not be used due to its toxicity

Consumers who have been exposed to hand sanitizer containing methanol and are experiencing symptoms should seek immediate treatment for potential reversal of toxic effects of methanol poisoning.

The details of the Alcohol Based Hand Sanitizers subject to the US FDA recall notification are as shown in the table below:

S/NBrand NameManufacturerNDC numberLOT NO
1All Clean Natural Hand sanitizer

 

 

All Clean Natural LTD

 

USA

NDC-74589-002-01All lots
2All day hand sanitizerSkin Guard 24   Atlanta USANDC-74840-402-01All Lots
3Esk biochem Hand sanitizerESK Biochem Ltd. MexicoNDC- 74589-007-01All Lots
4bio aaa Advance Hand Sanitizer 480mlAAA Cosmetics S A De CV  Mexico

 

Payless Janitorial Corporation Mexico

NDC-76987-402-01All Lots

 

 

5Body guard infusion administration setCME America All lots
6Bersih Hand Sanitizer Gel Fragrance FreeSoluciones Cosmetics  Ltd75165-000-01   and 75165-003-02

 

75165-004-01

75165-005-01

75165-006-01

75165-250-01

All Lots
7Bersih Antiseptic Alcohol 70% Topical Solution
hand sanitizer
Soluciones Cosmetics Lyd Mexico75165-600-01

 

 

All lots
8Blumen Clear Advanced Hand Sanitizer with
70% Alcohol with Glycerin and Aloe
4e Brands North AmericaNDC-60599-024-00All lots
9BLUMEN Advanced Instant Hand Sanitizer Clear with 70% Ethyl Alcohol with Glycerin & Vitamin E4e Brands North America60599-047-00-46All lots
10BLUMEN Clear LEAR Advanced Hand Sanitizer4e Brands North America60599-017-00

 

60599-018-01

All lots
11The Honeycreeper Hand Sanitizer4e Brands North America60599-020-00 -01All lots
12Pacific Coast Global Inc. and TritaniumIncredible Products SA de CV (Mexico)71761-000-01 71761-000-05 71761-000-10

 

71761-000-20 71761-000-22 71761-000-37

71761-000-99

All lots

Below is photograph of the KVM Hand sanitizer banned by the RFDA

NAFDAC implores importers, distributors, retailers and consumers to exercise caution and vigilance to avoid the distribution, sale and use of methanol alcohol-based hand sanitizers.

Members of the public in possession of methanol alcohol-based hand sanitizers are implored to discontinue sale or use and submit stock to the nearest NAFDAC office.

NAFDAC encourages the members the public to wash their hands often with soap and water for at least 20 seconds. If soap and water are not readily available, the NigeriaCenter for Disease Control and Prevention (NCDC) recommends the  use of  an alcohol-based hand sanitizer that contains at least 60 percent ethanol (also referred to as ethyl alcohol or 70% isopropanol as part of the measures put in place to mitigate the possible risk of spreading the COVID 19 Virus.

NAFDAC encourages health care professionals, consumers and patients to report adverse events related to the use of any Hand sanitizer to the nearest NAFDAC office, NAFDAC PRASCOR (20543 TOLLS FREE from all networks) or via pharmacovigilance@nafdac.gov.ng

NAFDAC……..Customer-focused, Agency-minded!!!

Signed ManagementManagement

Source: nafdac.gov.ng

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