The Switzerland-based Sunstar Americas, Inc., the maker of GUM Paroex Chlorhexidine Gluconate Oral Rinse, 0.12%, recalled its mouthwash due to microbial contamination, according to an announcement from the U.S. Food and Drug Administration (FDA).
Bottles of this specific mouthwash that have an expiration date between June 30, 2022 and September 30, 2022 might be contaminated with Burkholderia lata, according to the FDA. The company recalled 37 batch numbers – or lots – after they learned that 29 people have been infected, The State reported. (RELATED: Egg recall: FDA finds evidence of salmonella in chicken feed)
RECALL ALERT: Recalled mouthwash can be ‘particularly unsafe’ for people infected with COVID-19 https://t.co/flHUmbctEP
— Miami Herald (@MiamiHerald) December 29, 2020
Use of the mouthwash may cause “oral and, potentially, systemic infections requiring antibacterial therapy” in someone who otherwise has a competent immune system, according to the FDA. “In the most at-risk populations, the use of the defective product may result in life-threatening infections, such as pneumonia and bacteremia.”
The Paroex mouthwash was distributed in the United States to dental offices, dental distributors, dental schools, pharmacy wholesalers and pharmacies, according to the FDA. Sunstar is notifying its distributors and customers by USPS Priority mail and is arranging logistics for the return of all recalled items, according to the FDA.
Consumers can contact Sunstar by phone with questions at 1-800-528-8537 or by email at us.pcr@us.sunstar.com Monday to Friday from 8 a.m. to 5 p.m. Central Standard Time, according to the FDA.