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Buzzagogo, LLC manufactured and marketed "Allergy Bee Gone for Kids," an unapproved nasal swab drug product with claims to relieve sinus congestion, sneezing, and runny nose, violating section 505 of the FD&C Act. FDA laboratory testing found the product was adulterated with multiple Bacillus species (including B. cereus, B. amyloliquefaciens, and B. atrophaeus), making it unsafe for use in young children and violating section 501(a)(1) of the FD&C Act. The company distributed this contaminated, unapproved drug through interstate commerce via its website, constituting violations of section 301 of the FD&C Act.