Sunstar Americas has expanded a recall for GUM Paroex mouthwash after 29 people were infected with the bacteria Burkholderia lata, which can potentially worsen an underlying COVID infection.
The original recall back in October 2020 was limited to 37 lots of the mouthwash. Now, the company has expanded the recall to include all lots with expiration dates ranging from 12/31/2020 through 9/30/2022.
Use of a contaminated mouthwash product could lead to “oral and, potentially, systemic infections requiring antibacterial therapy,” as well as “life-threatening infections, such as pneumonia and bacteremia.”
The recall also mentions COVID risks: “Use of the contaminated product on patients with pre-existing respiratory conditions, including those infected with Covid-19, is particularly unsafe.”
The recall involves GUM Paroex® Chlorhexidine Gluconate Oral Rinse USP, 0.12%, including 16 fl.oz. Amber Bottles (NDC# 052376-021-02 and Product Code 1789P) and 4 fl.oz. Amber Bottles (NDC# 052376-021-04 and Product Code 1788P).
GUM Paroex is a prescription oral rinse mouthwash, available through healthcare professionals for the treatment of gingivitis. It was distributed nationwide to dental offices, dental distributors, pharmaceutical wholesalers, dental schools, and pharmacies.