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FDA Violations

Soho Fresh Line is Recalled Due to Methanol Contamination

— January 21, 2021

Essaar voluntarily withdrawals rubbing alcohol for containing methanol.

The Food and Drug Administration (FDA) announced this month that Essaar, Inc. has voluntarily withdrawn its hand sanitizer due to concerns that is contaminated with alcohol.  The specific lot to be withdrawn is labeled 200528303 with UPC 7502268987367 and contains Soho Fresh 70% rubbing alcohol in 33.81 oz. clear plastic bottles.  The FDA performed an analysis of the product and found methanol, a potentially poisonous substance.

“Substantial methanol exposure can result in nausea, vomiting, headache, blurred vision, permanent blindness, seizures, coma, permanent damage to the nervous system or death,” the FDA warned.  Using Essaar’s contaminated line on the skin leaves consumers at risk of the toxin soaking in and causing adverse effects.  Young children who accidently ingest it and adolescents and adults who drink it as an ethanol alternative are at highest risk.

Soho Fresh Line is Recalled Due to Methanol Contamination
Photo by Martijn Baudoin on Unsplash

Soho Fresh was distributed to retailers nationwide, and Essaar Inc. is notifying both distributors and consumers who purchased it by email and mail, as well as managing returns.  Consumers should contact their healthcare provider if they have experienced issues which could be related to the product, and if they’ve purchased from this lot, they are urged to stop using it and discard or return any remaining product.

Those who have unused, contaminated bottles of Soho Fresh should return them to the store for a full refund or call Essaar Inc. at 201-647-7606 Monday to Friday 9am to 5pm, Eastern Standard Time, the company announced.  This is a voluntary withdrawal, and, to date, Essar Inc. said it has not received any reports of accidental poisoning.

As the world continues to battle COVID-19, hand sanitizers have become a household staple.  The Centers for Disease Control and Prevention (CDC) and other regulatory bodies have pushed for better personal hygiene measures.  Unfortunately, many of these, too, have been found to contain dangerous levels of methanol.

The FDA announced last fall that some companies are coming out with product lines that resemble beer cans, water, juice and vodka bottles, and children’s food pouches that contain methanol.  The drink-like packaging further encourages both youth and adults to consume the products, and the CDC announced it is aware of fatalities.

FDA Commissioner Stephen Hahn said, “These products could confuse consumers into accidentally ingesting a potentially deadly product,” and the agency warned, “Products packaged to appear as drinks, candy or liquor bottles, as well as products marketed as drinks or cocktails because their appearance could result in accidental ingestion or encourage ingestion.  Children are particularly at risk with these products since ingesting only a small amount of hand sanitizer may be lethal in a young child.”

The CDC recommends consumers use an alcohol-based hand sanitizer that contains at least 60 percent ethanol.  The FDA warned last March, “Certain hand sanitizers that may not contain a sufficient amount of ethyl alcohol or isopropyl alcohol.”  This led to companies scrambling to increase alcohol levels in their sanitizers, and in some cases, pushing the limits from COVID-approved to downright deadly.


Essaar Inc. Issues Voluntary Nationwide Recall of Rubbing Alcohol Contaminated with Methanol

FDA Warns of New Sanitizer Packaging, Methanol Contamination

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