Drug product
Allergy Bee Gone for Kids Nasal Swab Remedy 0.33 FL OZ (10 mL) tubes, UPC Code 860002022116
D-1160-2022
Product summary
- Firm
- Buzzagogo, LLC
- Event
- Event 90382
- Status
- Terminated
- Classification
- Class I
- Quantity
- 28,328 tubes
- Official record key
drug-enforcement:D-1160-2022
Official wording
Reason: Microbial contamination of non-sterile product: FDA laboratory analysis found product to contain elevated levels of yeast and mold as well as the presence of Bacillus cereus.
Code information: Lot #: 2006491, Exp. Date 08/24
Distribution pattern: Product was distributed via the internet to consumers, retailers and to distributors who may have further distributed the product.
Derived failure modes
-
Microbial contamination
Microbial contamination