Elevated risk U.S. Food and Drug Administration

Florance Morris Antiseptic Hand Sanitizer, 70% Alcohol recall: Potential Methanol Contamination

Recall published 6+ years ago

Potential Methanol Contamination

Florance Morris Prescription & OTC drugs — recalled prescription & otc drugsFlorance Morris 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: Harmful chemical exposure

A chemical contaminant is behind this recall. The official notice names the substance, and that name is what a clinician or Poison Control will want to hear.

What the notice says: Ethanol levels below the label claim can result in a lack of efficacy.

Why it matters: A chemical that should not be present at this level was found in the product. Depending on the substance, the concern may be a burn or irritation on contact, or a long-term risk from repeated exposure.

Symptoms and when to call a doctor

For a splash or spill, rinse the skin or eyes with running water for 15 to 20 minutes and remove contaminated clothing. If the product was swallowed, or if there is any trouble breathing, call Poison Control on 1-800-222-1222, which operates free and around the clock — or 911 if the person is collapsing, struggling to breathe or unconscious. Take the container or a photo of the label with you to any appointment.

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
August 17, 2020
Risk level
Elevated risk
Issued by
U.S. Food and Drug Administration
Brand
Florance Morris
Product type
Prescription & OTC drugs
Distribution
Florida

Products covered by this recall

Antiseptic Hand Sanitizer, 70% Alcohol

What the company announced

Grupo Asimex de Mexico SA de CV is voluntarily recalling all lots of FLORANCE MORRIS Antiseptic Hand Sanitizer, 70% Alcohol, packaged in 8 fl oz bottles and 1L bottles to the consumer level. The products have the potential to contain methanol (wood alcohol) and be sub-potent for the ethanol content.

Risk Statement: The use of sub-potent hand sanitizer products can have adverse health consequences related to infections. Ethanol levels below the label claim can result in a lack of efficacy. In addition, methanol has inferior antiseptic properties compared to ethanol. 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 person 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, Grupo Asimex de Mexico SA de CV has not received reports of adverse events related to this recall.

Recalled Products: These products are used as hand sanitizers and marketed to help decrease bacteria on the skin when soap and water are not available. The recalled products are as follows:

Product, Sizes and LOT:

FLORANCE MORRIS Antiseptic Hand Sanitizer

8 fl oz, 1 L

LOT CODES: 200520673, 200520674, 200525677, 200601685

The Hand Sanitizer is packaged in an 8 oz. and 1L plastic clear bottles with flip-top caps. Product was distributed in the state of FLORIDA in the United States through one distributor.

Grupo Asimex de Mexico is notifying its distributor by recall letter and consumers via this press release. Grupo Asimex de Mexico is arranging for the return and refund of all recalled products. Consumers/distributors that have the product subject to this recall should stop using/ distributing/ selling the Hand Sanitizer and return it to the place of purchase.

Consumers with questions regarding this recall can contact Grupo Asimex de Mexico SA de CV during business hours to the following email: [email protected] Event: Recall

Consumers should contact their physician or healthcare provider if they experienced any problems that may be related to the use of 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.

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 9 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.

  • 70
  • 1 L
  • 200520673
  • 200520674
  • 200525677
  • 200601685

Package size

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

  • 8 fl oz
  • 1 L
  • 8 oz

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 Chemical

Florance Morris — A chemical contaminant is behind this recall. The official notice names the substance, and that name is what a clinician or Poison Control will want to hear.

  1. Stop using the product and keep it away from children and pets.
  2. If anyone has symptoms, call Poison Control on 1-800-222-1222 rather than guessing.
  3. Do not pour it down a drain or into a bin without checking local hazardous-waste rules, and never mix it with another cleaner.
  4. Ventilate the room if the product was sprayed or applied there.

Claiming your refund, repair or replacement

The recalling company decides the remedy and funds it. You should never pay for a recall repair or for return shipping.

  • Use the company contact on this page first. Most firms run a dedicated recall page with a claim form that is far quicker than their main support line.
  • If you bought it from a retailer rather than the brand, try both. Target, Walmart and Amazon often refund recalled goods from the order history.
  • If the company stops responding, escalate to the CPSC. Firms under a recall order have reporting duties to the agency.
  • Have the model number, the date code and your photos ready. Many companies issue store credit by default — ask for cash or a card reversal if you would rather have it.

Remedy named in the notice: Grupo Asimex de Mexico is arranging for the return and refund of all recalled products.

Company contact: Grupo Asimex de Mexico SA de CV — Consumers: Grupo Asimex de Mexico SA de CV, [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 Florance Morris prescription & otc drugs recalled?

Potential Methanol Contamination Ethanol levels below the label claim can result in a lack of efficacy.

How do I know if I have the recalled product?

Match the codes printed on your package against the notice: lot code 70, 1 L, 200520673. 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?

Stop using the product and keep it away from children and pets.

Can I get my money back?

The notice says: Grupo Asimex de Mexico is arranging for the return and refund of all recalled products.

Which states were affected?

The notice lists Florida.

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