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US FDA Calls And Three Mexican Firms Recall Contaminated Sanitizers, But A Fourth Hangs Up

Executive Summary

Four warnings, like previous letters FDA submitted to Mexican firms making methanol-containing hand sanitizers, which have been linked to deaths and other adverse events, indicate the targeted firms apparently entered US market for the products after the agency loosened manufacturing controls.

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Claims Other Than COVID-19 Surface But Contaminated Sanitizer Spreads In US Warnings

FDA inspectors in the eastern US took their turn recently at finding violations for dietary supplement manufacturing marketing unrelated to COVID-19. Agency also warned two more Mexican businesses that exploited its temporary loosening of regulations for producing alcohol-based hand sanitizers.

US FDA Adds Hand Sanitizer Import Alert Category After COVID-19 Production Surge Turned Deadly

Action responds to methanol contamination in hand sanitizers manufactured in Mexico and marketed in the US under numerous brands that followed a loosening standards for the products to drive a swift increase in production and meet surging demand during the coronavirus pandemic.

US FDA Clarifies Testing In Sanitizer Production Temporary Guidances To Tighten Compliance

The agency clarifies in documents providing temporary guidance on preparing or compounding alcohol-based hand sanitizer products, and manufacturing alcohol for those products, that each lot of alcohol obtained from another source should be tested for methanol.

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