Highest risk U.S. Food and Drug Administration

Cleaner Hand Sanitizer recall: Potential Presence of Methanol (Wood Alcohol)

Recall published 6+ years ago

Potential Presence of Methanol (Wood Alcohol)

Cleaner Prescription & OTC drugs — recalled prescription & otc drugsCleaner 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 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
September 8, 2020
Risk level
Highest risk
Issued by
U.S. Food and Drug Administration
Brand
Cleaner
Product type
Prescription & OTC drugs
Distribution
Nationwide

Products covered by this recall

Cleaner Hand Sanitizer

What the company announced

Estado de México, México, DMM VISSION, S.A. de C.V. is voluntarily recalling five lots of Cleaner Hand Sanitizer, 500 mL and 1,200 mL plastic clear bottles with white tops currently in US distribution to the consumer level. This recall is being initiated out of abundance of caution due to detection of methanol (wood alcohol) in hand sanitizer sample manufactured at the same facility.

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 DMM VISSION has not received reports of adverse events related to this recall.

The product is used as a hand sanitizer and are packaged in 500ml and 1200ml plastic clear bottles with white tops. The lot numbers are LC2020407, LC2020408, LC2020502, LC2020504, LC2020507. This product was first distributed nationwide to wholesale distributors on April 27, 2020 and finished on June 9th, 2020. The recalled products are as follows:

  • Product(s): Cleaner Hand Sanitizer · Country of Origin: Mexico · Product Size: 1200 ML · Product Label: See Product Image Below · Lot number: LC2020407 · NDC: 75799-000-04 · Expiry Date: April/2021
  • Product(s): Cleaner Hand Sanitizer · Country of Origin: Mexico · Product Size: 500 ML · Product Label: See Product Image Below · Lot number: LC2020408 · NDC: 75799-000-02 · Expiry Date: April /2021
  • Product(s): Cleaner Hand Sanitizer · Country of Origin: Mexico · Product Size: 1200 ML · Product Label: See Product Image Below · Lot number: LC2020502 · NDC: 75799-000-04 · Expiry Date: May/2021
  • Product(s): Cleaner Hand Sanitizer · Country of Origin: Mexico · Product Size: 1200 ML · Product Label: See Product Image Below · Lot number: LC2020504 · NDC: 75799-000-04 · Expiry Date: May/2021
  • Product(s): Cleaner Hand Sanitizer · Country of Origin: Mexico · Product Size: 1200 ML · Product Label: See Product Image Below · Lot number: LC2020507 · NDC: 75799-000-04 · Expiry Date: May/2021

DMM VISSION is notifying its distributors by phone calls, emails and/or mailed letters and is arranging for return of all recalled products. Consumers, distributors, and retailers that have product which is being recalled should stop use or distribution and return to place of purchase.

Consumers with questions regarding this recall can contact DMM VISSION by phone (+52) 5547578351 or email to [email protected] on Monday through Friday from 9 am and 5 pm, CST. 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. Consumers/distributors/retailers that have the above listed lots Cleaner Hand Sanitizer should stop using or distributing the products immediately and mail the products to 700 County Line Rd., Lakewood, NJ, 08701.

Contact Name: José Álvarez

Phone Number: (+52) 5547578351

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's update

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

Lot or batch code

Usually ink-stamped near the seam, the cap or the bottom of the pack.

  • 500
  • 200
  • LC2020408
  • LC2020502
  • LC2020504
  • LC2020507
  • LC2020407

Best-by / use-by date

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

  • April/2021
  • 2021
  • May/2021
  • May/2021. DMM VISSION

NDC number

On the carton and again on the bottle or blister label.

  • 75799-000-04
  • 75799-000-02

Package size

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

  • 500 mL
  • 200 mL
  • 1200 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

Cleaner — 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. 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.

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.

Company contact: Estado de México, México, DMM VISSION, S.A. de C.V — Consumers: DMM VISSION, José Álvarez, (+52) 5547578351, [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 Cleaner prescription & otc drugs recalled?

Potential Presence of Methanol (Wood Alcohol) 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: lot code 500, 200, LC2020408; best-by date April/2021 or 2021. 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?

A photo of the label and lot code is accepted by most grocers, and so is a card statement line showing the purchase.

Where was the recalled product sold?

It was distributed nationwide.

Related recalls