Sunstar Americas recalls mouthwash

Dental Tribune International

Thu. 7. January 2021

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SCHAUMBURG, Ill., U.S.: At the end of December, Sunstar Americas voluntarily recalled one of its mouthwashes. The company is a member of the Sunstar Group, a global company headquartered in Switzerland and a leader in the oral care industry. It gave bacterial contamination as the reason for the withdrawal.

On Oct. 27, the company had already announced the recall of the product Paroex Chlorhexidine Gluconate Oral Rinse USP, 0.12%, bearing expiration dates from June 30, 2022, to Sept. 30, 2022. Now, Sunstar Americas has extended the recall to all of these products with expiration dates between Dec. 31, 2020, and Sept. 30, 2022, as stated in a company announcement.

The product in question. (Image: Sunstar Americas)

According to Sunstar Americas, the product may be contaminated with the bacteria Burkholderia lata. Whereas this may lead to “oral and, potentially, systemic infections requiring antibacterial therapy” in the healthy population, use of the contaminated product may result in “life-threatening infections, such as pneumonia and bacteremia” in risk groups.

Presently, 29 cases associated with the product have been reported. The announcement stated that affected patients had tested positive for B. lata infections. Use of the mouthwash by patients with pre-existing respiratory conditions, including by those infected with SARS-CoV-2, was classified as particularly unsafe.

The mouthwash had been distributed to dental offices, dental distributors, pharmaceutical wholesalers, dental schools and pharmacies in the U.S. Sunstar Americas has notified its distributors and customers and arranged for the return of the recalled products. “Patients, pharmacies, and health care facilities in possession of these products should stop using and dispensing immediately,” stated the company.

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