Highest risk U.S. Food and Drug Administration

Always Be Clean, Just Hand Sanitizer recall: Products labeled to contain methanol

Recall published 6+ years ago

Products labeled to contain methanol

The hazard: Harmful chemical exposure

This notice concerns a chemical found in the product at a level regulators consider unsafe, which is usually caught by laboratory testing rather than by anybody noticing a problem.

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: 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 29, 2020
Risk level
Highest risk
Issued by
U.S. Food and Drug Administration
Brand
Always Be Clean, Just
Product type
Prescription & OTC drugs
Distribution
Nationwide
UPC codes
375091202016, 375091202023, 375091202030, 703123998659, 703123998598

Products covered by this recall

Hand Sanitizer

What the company announced

Open Book Extracts (OBX) is voluntarily recalling to the consumer level all lots of Always Be Clean Hand Sanitizer and Just Hand Sanitizer that are labeled to contain methanol.

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 accidentally ingest these products and adolescents and adults who drink these products as an alcohol (ethanol) substitute, are most at risk for methanol poisoning.

OBX sources hand sanitizer from a leading global chemical and ingredient distributor, and has verified through a third-party lab that the hand sanitizer does not contain reportable levels of methanol. The supplier updated the Safety Data Sheet (SDS) to remove methanol since it is below the reportable level, and we updated the labels accordingly.

These products are used as hand sanitizers and marketed to help decrease bacteria on the skin when soap and water are not available.

The mislabeled hand sanitizer was packaged in single-use packets and multi-count boxes using the following NDC and Lot codes:

  • Name of Product: Always Be Clean hand sanitizer · NDC: 75091-2020-1 75091-2020-2 75091-2020-3 · Size: Single snaps 100 Count 25 Count · UPC: 375091202016 375091202023 375091202030 · Lot: ES8-200514
  • Name of Product: Just Hand Sanitizer · NDC: 78065-2020-1 78065-2020-2 · Size: Single Snaps 100 Count · UPC: 703123998659 703123998598 · Lot: ES9-200610

The mislabeled hand sanitizer was packaged from May 14, 2020 through June 1, 2020 and sold from May 15, 2020 through July 16, 2020 Nationwide in the USA to businesses for internal use.

OBX has notified all distributors via phone and email and is replacing all of the mislabeled product. While OBX believes that all mislabeled units have been recovered or, in the case of Just Hand Sanitizer, were relabeled prior to sale, anyone with questions regarding this recall or are in possession of Just Hand Sanitizer or Always Be Clean Hand Sanitizer from the above-listed lots that list methanol as an inactive ingredient may contact Open Book Extracts at [email protected] or 917-536-1194 (9 a.m.- 5 p.m. ET) to replace the hand sanitizer free of charge.

Distributors or businesses that have product labeled to contain methanol should stop distribution and return to place of purchase. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to 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.

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 11 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.

  • 375091202016
  • 375091202023
  • 375091202030
  • 703123998659
  • 703123998598

Lot or batch code

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

  • ES8-200514
  • ES9-200610

NDC number

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

  • 75091-2020-1
  • 78065-2020-1

Package size

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

  • 100 Count
  • 25 Count

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

Always Be Clean, Just — This notice concerns a chemical found in the product at a level regulators consider unsafe, which is usually caught by laboratory testing rather than by anybody noticing a problem.

  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.

How the remedy works

CPSC recalls specify one of three remedies, and which one you get is not negotiable — but how smoothly it goes often is.

  • A refund means the purchase price back, sometimes prorated by age for durable goods. Ask how they calculated it if the figure looks low.
  • Several recalls now ask you to destroy the item and send a photo as proof. Register the claim before you do that, never after.
  • Return shipping is the company’s cost. If you are asked to pay it, push back.
  • A repair kit is shipped free and is designed to be fitted at home; if you cannot fit it, ask whether they will arrange installation.

Company contact: Open Book Extracts — Consumers: 917-536-1194, [email protected] — Media: 440-413-0371, [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 Always Be Clean, Just prescription & otc drugs recalled?

Products labeled to contain methanol 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 375091202016, 375091202023, 375091202030; lot code ES8-200514, ES9-200610. 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?

A refund means the purchase price back, sometimes prorated by age for durable goods. Ask how they calculated it if the figure looks low.

Where was the recalled product sold?

It was distributed nationwide.

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