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Sunstar Americas, Inc. on Oct. 27 voluntarily recalled its prescription oral rinse due to a possible microbial contamination.
A U.S. Food and Drug Administration news release states the company’s Paroex Chlorhexidine Gluconate Oral Rinse, 0.12% product could be contaminated with the bacteria Burkholderia lata and may result in life-threatening infections, such as pneumonia and bacteremia for the most at-risk users.
The oral rinse, used primarily for treatment of gingivitis, has an expiration date between June 30, 2022, and Sept. 30, 2022.
The product is distributed nationwide to dental offices, dental distributors, pharmaceutical wholesalers, dental schools and pharmacies and packaged as:
According to the FDA, Sunstar is notifying its direct distributors and customers by U.S. Postal Service priority mail and is arranging for the return of all recalled products. Patients, pharmacies and health care facilities that possess the products should stop using and dispensing them immediately.
To date, no adverse events have been reported to the company related to the recall.
Dentists with questions about the recall can contact Sunstar Americas, Inc. at 800.528.8537 or by email [email protected] Monday-Friday from 8 a.m. to 5 p.m. CST.