Background

All alcohol-based hand sanitizers from Mexico have been placed on a Food and Drug Administration import alert, the FDA’s first-ever country-wide import alert for any category of drug product.

The FDA states that during the ongoing COVID-19 pandemic it has seen a sharp increase in hand sanitizer products from Mexico that were labeled to contain ethanol (also known as ethyl alcohol) but tested positive for contamination with methanol (also known as wood alcohol), which can be toxic when absorbed through the skin and life-threatening when ingested.

Under the new action, alcohol-based hand sanitizers from Mexico offered for import are subject to heightened FDA scrutiny and may be detained. However, as part of their entry review FDA staff will consider any specific evidence offered by importers or manufacturers that the hand sanitizers were manufactured according to U.S. current good manufacturing practice requirements.

The FDA reminds importers, manufacturers, distributors, and repackagers that they are responsible for the quality of their products and urges manufacturers to test their raw ingredients to ensure they meet labeling specifications and are free from harmful contamination.

For more information, please contact Domenic Veneziano at (202) 734-3939.

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