Sunstar Americas, Inc announced the voluntary recall of GUM® Hydral Dry Mouth Relief Oral Spray products due to possible contamination with the bacteria Burkholderia cepacia.
The recall applies to products bearing an expiration date from 11/2021 through 5/2022. The full list of affected lots can be found here.
GUM® Hydral Dry Mouth Relief Oral Spray is indicated to relieve and manage the symptoms of dry mouth. According to the Company, “use of the defective product in the immunocompetent host may result in oral and, potentially, systemic infections requiring antibacterial therapy,” and may potentially result in life-threatening infections in the most at-risk populations.
To date, there have been no reported adverse events related to this recall. Consumers in possession of the affected product should discontinue use. Any adverse events associated with the recall should be reported to the FDA’s MedWatch program.
For more information regarding this recall, contact Sunstar Americas at (800) 528-8537 or email [email protected].
Sunstar Americas, Inc. issues voluntary nationwide recall of GUM® Hydral Dry Mouth Relief Oral Spray due to possible microbial contamination. [press release]. Chicago, IL: Sunstar Americas, Inc.; February 18, 2021.