Buzzagogo, LLC
85 Lakeview Drive
Nottingham , NH 03290
United States
office@buzzagogo.comFEI 3012197003Issued Jan 18, 2023Center for Drug Evaluation and Research | CDER
Source: FDA, published letter. FDA published this warning letter; View Letter opens FDA's copy. To check it, open FDA's record for this establishment, listed under FEI 3012197003.
Violations2
Issue DateJan 18, 2023
Product TypeDrugs
StatusOpen
Letter Details
Firm
Buzzagogo, LLC
Location
Buzzagogo, LLC
85 Lakeview Drive
Nottingham , NH 03290
United States
office@buzzagogo.com
FEI Number
3012197003
Country
United States
Issue Date
January 18, 2023
Issuing Office
Center for Drug Evaluation and Research | CDER
Product Type
Drugs
Status
Open
Summary
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.
Buzzagogo, LLC FDA Warning Letter, January 18, 2023