Original Post
Summary
Company Announcement Date: June 07, 2022
FDA Publish Date: June 07, 2022
Product Type: Drugs
Reason for Announcement: Product contains elevated levels of Bacillus cereus
Company Name: Buzzagogo Inc.
Brand Name: Allergy Bee Gone for Kids
Product Description: Nasal Swab Remedy
Company Announcement
FOR IMMEDIATE RELEASE – June 07, 2022 – Nottingham, NH, Buzzagogo Inc. is voluntarily recalling one lot of Allergy Bee Gone for Kids Nasal Swab Remedy to the consumer level due to potential microbial contamination. FDA testing found some product to contain elevated levels of yeast & mold and may contain the bacteria Bacillus cereus.
Risk Statement: In immunocompromised patients, the use of the affected product could potentially result in severe or life-threatening adverse events such as bacteremia/sepsis, pneumonia, invasive fungal rhinosinusitis, or disseminated fungal infection. In non-immunocompromised patients, the population most likely to use the product, the use of the defective product may result in infectious complications, for instance bacteremia or noninvasive fungal rhinosinusitis, but in this population the infections are expected to be less severe and more readily responsive to treatment. To date, Buzzagogo, Inc. has not received any complaints related to microbial concerns or reports of adverse events related to this recalled lot.
The product is used to lessen seasonal allergy symptoms and is packaged in individual tubes for topical nasal application. The affected Allergy Bee Gone for Kids Nasal Swab Remedy lot is 2006491 with expiration date 8/2024 and UPC code 860002022116. The product can be identified by locating the lot number and expiration date on the bottom of the product carton. Allergy Bee Gone for Kids Nasal Swab Remedy, lot # 2006491, was distributed Nationwide to wholesale distributors, retail stores and online on Amazon.com and the company web site.
Buzzagogo, Inc. places the utmost emphasis on patient safety and product quality at every step in the manufacturing and supply chain process. Buzzagogo, Inc. is notifying its distributors and customers by email and is arranging for return or replacement of all recalled products. Consumers, distributors or retailers that have Allergy Bee Gone for Kids Nasal Swab Remedy, lot # 2006491, should stop using the product, discard any remaining product and contact the company at [email protected] for a full refund. We seek to minimize all inconvenience this may cause consumers and are committed to their complete satisfaction.
Consumers with questions regarding this recall can contact Buzzagogo, Inc. by phone at (800) 963-2861or via e-mail to [email protected] Monday – Friday from 9am to 5pm EDT. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to using this drug product.
Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail or by fax.
- Complete and submit the report Online: www.fda.gov/medwatch/report.htm
- Regular Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.
Company Contact Information
Consumers:Buzzagogo, Inc. 800-963-2861 [email protected]
Product Photos
