ITB HOLDINGS LLC | 390 North Orange Avenue, Suite 2300 | Orlando, FL 32801 | United States
Methanol
Hand Sanitizers
FDA WARNINGS FOR METHANOL IN HAND SANITIZERS

There is an increase on the market of hand sanitizers labeled as containing ethanol, but instead and in fact contain methanol, which can cause

■ nausea

■ vomiting

■ headache

■ blurred vision

■ permanent blindness

■ seizures

■ coma

■ permanent damage to the nervous system

■ death

The U.S. Food and Drug Administration (FDA) is warning manufacturers, exporters, importers and distributors: Methanol is not an acceptable active ingredient for hand sanitizers and must not be used due to its adverse events including deaths.

HAND SANITIZERS TO AVOID IMPORTING, DISTRIBUTING OR USING

FDA is warning consumers and health care professionals not to use Durisan Antimicrobial Solutions Hand Sanitizer manufactured by Sanit Technologies LLC doing business as Durisan in Sarasota, Florida, due to microbial contamination including high levels of Burkholderia cepacia complex and Ralstonia pickettii, which can lead to serious infections, including infection of the skin, soft tissues, lungs or bloodstream.

The agency urges consumers not to use certain hand sanitizer products:

■ Tested by FDA and found to contain methanol or 1-propanol
■ Labeled to contain methanol
■ Tested and is found to have microbial contamination
■ Being recalled by the manufacturer or distributor
■ Subpotent, meaning it has less than the required amount of ethyl alcohol, isopropyl alcohol or benzalkonium chloride
■ Purportedly made at the same facility as products that have been tested by FDA and found to contain methanol or 1-propanol
■ Packaged in a container that resembles a food/beverage container that presents increased risk of accidental ingestion

ADVERSE EVENT REPORTING

The U.S. Food and Drug Administration encourages health care professionals, consumers and patients to report adverse events or quality problems experienced with the use of hand sanitizers to FDA’s MedWatch Adverse Event Reporting program.

You may

  • Complete and submit the report online
  • Download and complete the form, then submit it via fax at 1-800-FDA-0178
OTC DRUG ESTABLISHMENT REGISTRATION

Hand sanitizers are regulated as over-the-counter (OTC) drug products. Therefore, manufacturers are required to register their establishments with the U.S. Food and Drug Administration, and list their products annually.

All establishments currently registered with the FDA are expected to renew their registration before December 31, 2021.

Here is your chance to switch U.S. Agent, and enjoy low fees.

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