Highest risk U.S. Food and Drug Administration

Bersih Hand Sanitizer Gel recall: Potential Methanol Contamination

Recall published 6+ years ago Last updated

Potential Methanol Contamination

Bersih Prescription & OTC drugs — recalled prescription & otc drugsBersih Prescription & OTC drugs — recalled prescription & otc drugs (photo 2)Bersih Prescription & OTC drugs — recalled prescription & otc drugs (photo 3)Bersih Prescription & OTC drugs — recalled prescription & otc drugs (photo 4)
4 photos published by U.S. Food and Drug Administration with the recall notice.

The hazard: Undeclared allergen or ingredient

An ingredient subject to mandatory disclosure was left off the packaging, which is what the agency classes as misbranding.

What the notice says: Risk Statement: Substantial methanol exposure can result in nausea, vomiting, headache, blurred vision, permanent blindness, seizures, coma, permanent damage to the nervous system or death.

Why it matters: An ingredient that U.S. law requires to be declared is present but missing from the label. People who avoid that ingredient cannot make a safe choice from the packaging.

Symptoms and when to call a doctor

An undeclared allergen is a danger only to people allergic or intolerant to that ingredient. For everyone else the food is safe. Reactions range from an itchy mouth, hives, stomach cramps or vomiting through to anaphylaxis — swelling of the lips, tongue or throat, a tight chest, wheezing, a sudden drop in blood pressure or collapse. If anaphylaxis is suspected, use an epinephrine auto-injector straight away and call 911, even if the symptoms seem to settle, because a second wave can follow hours later.

This page is general information, not medical advice. If you feel unwell, a clinician who can see you is the only person able to judge your case.

Recall details

Published
July 14, 2020
Risk level
Highest risk
Issued by
U.S. Food and Drug Administration
Brand
Bersih
Product type
Prescription & OTC drugs
Distribution
Nationwide
UPC codes
816822026667, 7503007103178

Products covered by this recall

Hand Sanitizer Gel

What the company announced

Soluciones Cosméticas voluntary recalled 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). This release provides additional information about the packaging for the recalled products .

Risk Statement: 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. To date Soluciones Cosméticas has not received reports of adverse events related to this recall.

The product is used as a hand sanitizer and is packaged in 16.9 ounce plastic clear bottles with blue tops or green tops with UPC Codes 816822026667 or 7503007103178 . The lot numbers range from 0100K01 to 0148K01. This product was distributed nationwide to wholesale distributors and retailers.

Soluciones Cosméticas is notifying its distributors by voluntary recall letter and consumers via this press release. Consumers that have the product subject to this recall should stop using and either contact Soluciones Cosméticas per the below for disposal instructions or return it to the place of purchase.

Consumers with questions regarding this recall can contact Soluciones Cosméticas at 866-912-8410 Monday through Friday 8am to 5pm Eastern Time or by email at [email protected] . Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to using this product.

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

Complete and submit the report Online

Regular Mail or Fax: Download form or call 1- 800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.

Original Press Release

FDA updates on hand sanitizers consumers should not use.

Reproduced from the company announcement posted on fda.gov. Links and contact forms in the original are not repeated here; the official notice below has them.

How this recall developed

The company posted 2 announcements about this recall on fda.gov. They are kept together on this page: the products, codes and places listed above are combined from all of them, and the announcement text comes from the most recent English version.

  1. July 14, 2020 — First announcement. Soluciones Cosméticas Issues Voluntary Nationwide Recall of Bersih Hand Sanitizer Gel Due to the Potential Presence of Undeclared Methanol (Wood Alcohol) Read it on fda.gov
  2. August 9, 2020 — Updated announcement. Soluciones Cosméticas Issues Voluntary Nationwide Recall of Bersih Hand Sanitizer Gel Due to The Potential Presence of Undeclared Methanol (Wood Alcohol): Updated August 7, 2020 Read it on fda.gov

Check your product

The notice names 3 codes you can read straight off the package. Type the one printed on yours and the list below narrows to it.

UPC / barcode

Read the twelve digits under the barcode on the package.

  • 816822026667
  • 7503007103178

Package size

Match the net weight or the piece count on the front of the pack.

  • 16.9 ounce

Codes are lifted verbatim from the FDA — Company recall announcements notice. A code that is missing here may still be covered — the official notice is the complete list.

What to do about Allergen

Bersih — An ingredient subject to mandatory disclosure was left off the packaging, which is what the agency classes as misbranding.

  1. Read the official notice above for the exact ingredient involved, then check whether anyone in your home avoids it.
  2. If nobody here avoids it, the product is safe to eat; the refund is still available if you would rather return it.
  3. If someone does avoid it, stop serving it and check anything already cooked with it.
  4. Warn anyone else who eats from your kitchen, including schools and childminders.

Refunds, and what else you can claim

The purchase price is the floor, not the ceiling. Where a recall caused you a real cost, say so.

  • Claim the refund at the store first; it is the fastest route and needs the least paperwork.
  • If you bought several packs over time, list them. Firms routinely settle for more than a single unit when a customer asks.
  • Medical costs, lost earnings or a spoiled event are not handled at the service desk. Write to the company contact on this page instead, with dates and documents.
  • Keep copies of everything you send. If a recall caused harm, that file is what any later claim rests on.

Remedy named in the notice: Consumers that have the product subject to this recall should stop using and either contact Soluciones Cosméticas per the below for disposal instructions or return it to the place of purchase.

Company contact: Soluciones Cosmeticas — Consumers: Soluciones Cosméticas, 866-912-8410, [email protected] — Media: Ignacio Puerto, +52 55 999 163 5838, [email protected]

The official notice

This page summarises a notice published by U.S. Food and Drug Administration. The agency notice is the authoritative version — read it before you act, and treat it as the final word if anything here looks different.

Open the FDA — Company recall announcements record U.S. Food and Drug Administration recalls

Questions people ask about this recall

Why was Bersih prescription & otc drugs recalled?

Potential Methanol Contamination Risk Statement: Substantial methanol exposure can result in nausea, vomiting, headache, blurred vision, permanent blindness, seizures, coma, permanent damage to the nervous system or death.

How do I know if I have the recalled product?

Match the codes printed on your package against the notice: UPC 816822026667, 7503007103178. If the code on your package is not on that list, your unit is outside the recall.

What should I do with it right now?

Read the official notice above for the exact ingredient involved, then check whether anyone in your home avoids it.

Can I get my money back?

The notice says: Consumers that have the product subject to this recall should stop using and either contact Soluciones Cosméticas per the below for disposal instructions or return it to the place of purchase.

Where was the recalled product sold?

It was distributed nationwide.

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