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Florida Dental Products Firm Fails Regulatory Checkup With COVID-19 Claims

ACON Labs Recalls At-Home Tests Approved In Europe But Sold In US

Executive Summary

Products Iotech International sells to health care providers and consumers are deemed unapproved new drugs and are misbranded due to claims to prevent and treat COVID-19. ACON Laboratories determined Flowflex SARS-CoV-2 Antigen Rapid Test (Self-Testing) is for sale in US without approval.

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