Recalled mouthwash can be ‘particularly unsafe’ for people infected with COVID-19
The recall of GUM Paroex Chlorhexidine Gluconate Oral Rinse for a possible bacterial contamination, limited to 37 lots when announced in October, has been expanded after the manufacturer learned of 29 people actually infected.
And Sunstar Americas got a little more detailed in this recall notice about the possible affects of the Burkholderia lata bacteria.
Using the contaminated mouthwash can lead to “oral and, potentially, systemic infections requiring antibacterial therapy. In the most at-risk populations, the use of the defective product may result in life-threatening infections, such as pneumonia and bacteremia.”
Also “Use of the contaminated product on patients with pre-existing respiratory conditions, including those infected with COVID-19, is particularly unsafe.”
The original recall covered 4-ounce and 1-pint, 16-ounce bottles, NDC Nos. 052376-021-04 and 052376-021-02, respectively, of the prescription oral rinse with expiration dates from 6/30/22 to 9/30/22.
Now, the expiration date range is 12/31/2020 to 9/30/2022 and all lots in that date range are included. All use of this oral rinse should stop.
Consumers with questions about the recall should contact Sunstar by phone at 800-528-8537, Monday through Friday, 9 a.m. to 6 p.m., Eastern time, or by email at us.pcr@us.sunstar.com.
Report any medical issues from using this mouthwash to a medical professional. Then, contact the FDA’s MedWatch Adverse Event Reporting program either via the FDA website or by faxing a form obtained at 800-332-1088.
‘Toxic’ methanol might be in hand sanitizer linked to the Census Bureau and an NBA team
A Whole Foods problem is ‘a pattern,’ the FDA says in an unprecedented warning letter
Vegetable product recalled from Florida’s Winn-Dixie, Fresco y Mas and Harveys stores
