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