Buzzagogo, LLC
FDA issued a warning letter to Buzzagogo, LLC regarding their 'Allergy Bee Gone for Kids' nasal swab product, finding it to be an unapproved new drug under section 505 of the FD&C Act based on disease-treatment claims on its labeling and website. FDA laboratory analysis also found the product adulterated with objectionable microbial contamination including Bacillus cereus, posing serious risk to children as young as one year old. The company had already conducted a voluntary recall of lot 2006491 in June 2022. FDA demanded a written response within 15 working days detailing corrective actions, and warned that failure to comply could result in seizure and injunction.
Flagged claims (5)
WHAT IS IT: Allergy Bee Gone for Kids is a homeopathic remedy that you swab in your nose to fight nasal allergy symptoms, inflammation and to protect your Booger Biome . . .. The super honeys in Allergy Bee Gone for Kids are anti-inflammatory, prebiotic, probiotic.
WHY MANUKA HONEY: . . . our super honey blend . . . is antimicrobial . . . probiotic, prebiotic . . .. It's also infused with known cold-fighting homeopathic ingredients to alleviate active symptoms. All of these things combined are what make Cold Bee Gone for Kids so effective at fighting cold, flu and allergies.
SUGGESTED USE: (Nasal Use Only) . . . helps alleviate common cold symptoms.
HOW IT WORKS: The science behind the Nasal Swab Method is that cold and flu viruses generally enter the body through our eyes, ears nose or throat . . .. Introducing our ingredients can help reduce the duration and severity of the illness.
Relieves sinus congestion, sneezing, runny nose and post-nasal drip
Required actions (4)
Please notify FDA in writing, within fifteen working days of receipt of this letter, of the specific steps you have taken to address any violations.
A comprehensive, independent assessment of the design and control of your firm's manufacturing operations, with a detailed and thorough review of all microbiological hazards.
A detailed risk assessment addressing the hazards posed by distributing drug products with potentially objectionable contamination. Specify actions you will take in response to the risk assessment, such as customer notifications and product recalls.
Failure to adequately address any violations may result in legal action including, without limitation, seizure and injunction.
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