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Regulatory Authorities Recall Alcohol Based Hand Sanitizers Containing Methanol

October 12, 2020,

The National Agency for Food and Drug Administration and Control (NAFDAC)  has received information from US FDA of the  recall of all alcohol- based hand 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/N Brand Name Manufacturer NDC number LOT NO
1 All Clean Natural Hand sanitizer

 

All Clean Natural LTD

USA

NDC-74589-002-01 All lots
2 All day hand sanitizer Skin Guard 24   Atlanta USA NDC-74840-402-01 All Lots
3 Esk biochem Hand sanitizer ESK Biochem Ltd. Mexico NDC- 74589-007-01 All Lots
4 bio aaa Advance Hand Sanitizer 480ml AAA Cosmetics S A De CV  Mexico

Payless Janitorial Corporation Mexico

NDC-76987-402-01 All Lots

 

5 Body guard infusion administration set CME America All lots
6 Bersih Hand Sanitizer Gel Fragrance Free Soluciones Cosmetics  Ltd 75165-000-01   and 75165-003-02

75165-004-01

75165-005-01

75165-006-01

75165-250-01

All Lots
7 Bersih Antiseptic Alcohol 70% Topical Solution
hand sanitizer
Soluciones Cosmetics Lyd Mexico 75165-600-01

 

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

60599-018-01

All lots
11 The Honeycreeper Hand Sanitizer 4e Brands North America 60599-020-00 -01 All lots
12 Pacific Coast Global Inc. and Tritanium Incredible 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 Nigeria Center 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 Management

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