Highest risk U.S. Food and Drug Administration

bio aaa Hand Sanitizer recall: Potential Undeclared Methanol Contamination

Recall published 6+ years ago

Potential Undeclared Methanol Contamination

bio aaa Prescription & OTC drugs — recalled prescription & otc drugsbio aaa Prescription & OTC drugs — recalled prescription & otc drugs (photo 2)
2 photos published by U.S. Food and Drug Administration with the recall notice.

The hazard: Undeclared allergen or ingredient

The food itself is fine. What is wrong is the label, and for the households that rely on that label it is a real risk.

What the notice says: Risk Statement: Substantial methanol exposure could result in nausea, diarrhea, vomiting, severe abdominal pain, 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
bio aaa
Product type
Prescription & OTC drugs
Distribution
Nationwide
UPC codes
525526281124

Products covered by this recall

Hand Sanitizer

What the company announced

AAA Cosmética, 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).

Risk Statement: Substantial methanol exposure could result in nausea, diarrhea, vomiting, severe abdominal pain, headache, blurred vision, permanent blindness, seizures, coma, permanent damage to the nervous system, or death. Persons using these products on their hands may be at risk; however young children who accidently ingest them and adolescents and adults who drink these products are most at risk for methanol poisoning. To date, AAA Cosmética has not received any complaints or adverse event reports related to this recall.

The product is used as a hand sanitizer and it is packaged in 480 mL plastic bottles. AAA Cosmetica is recalling the following bio aaa Advance Hand Sanitizer lots, all of which bear the expiration date of April 2022:

  • 20DF9001: 20DF9007 · 20DF9002: 20DF9008 · 20DF9003: 20DF9009 · 20DF9004: 20DF9010 · 20DF9005: 20DF9011 · 20DF9006: 20DF9012
  • 20DF9001: 20DF9013 · 20DF9002: 20DF9014 · 20DF9003: 20DF9015 · 20DF9004: 20DF9016 · 20DF9005: 20DF9017 · 20DF9006: 20DF9018
  • 20DF9001: 20DF9019 · 20DF9002: 20DF9020 · 20DF9003: 20DF9021 · 20DF9004: 20DF9022

The product can be identified by the images. Product was distributed Nationwide in the United States beginning in April 2020.

AAA Cosmetica has notified its distributor, who will help notify its customers by phone calls, emails, and letters. AAA Cosmetica is arranging for refund and destruction of recalled products. Consumers/distributors/retailers that have the above listed lots of bio aaa Hand Sanitizer should stop using or distributing the products immediately and mail the products to AAA Cosmetica at the address below for refund:

I.S.C. Forwarder Inc.

8400 San Lorenzo,

Laredo, Texas 78045

(956) 753 0225

Consumers with questions regarding this recall can contact AAA Cosmética by phone +525526281124 or e-mail to [email protected] Monday to Friday from 10:00 am to 5:00 pm Central Time. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug 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.

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.

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.

  • 525526281124

Best-by / use-by date

Printed beside the lot code, not on the price sticker.

  • April 2022

Package size

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

  • 480 mL

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

bio aaa — The food itself is fine. What is wrong is the label, and for the households that rely on that label it is a real risk.

  1. Read the official notice above for the exact ingredient involved, then check whether anyone in your home avoids it.
  2. Report any reaction to the FDA so it is recorded against this recall.
  3. If nobody here avoids it, the product is safe to eat; the refund is still available if you would rather return it.
  4. If someone does avoid it, stop serving it and check anything already cooked with it.

Getting a refund without the pack

The commonest reason people skip the refund is that they have already thrown the item away. That rarely matters.

  • A photo of the label and lot code is accepted by most grocers, and so is a card statement line showing the purchase.
  • Store credit is often offered first. You can ask for the original payment method instead, and it is normally granted.
  • No photo either? Ask anyway. Grocery chains settle recall refunds at the service desk because disputing them costs more than paying them.
  • For a multi-pack or a case, ask for the full purchase price rather than a per-unit figure — the recall covers what you paid.

Remedy named in the notice: AAA Cosmetica is arranging for refund and destruction of recalled products.

Company contact: AAA Cosmetica, S.A. de C.V. — Consumers: AAA Cosmética, +525526281124, [email protected] — Media: Michele Pla, +525510482804

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 bio aaa prescription & otc drugs recalled?

Potential Undeclared Methanol Contamination Risk Statement: Substantial methanol exposure could result in nausea, diarrhea, vomiting, severe abdominal pain, 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 525526281124; best-by date April 2022. 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: AAA Cosmetica is arranging for refund and destruction of recalled products.

Where was the recalled product sold?

It was distributed nationwide.

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