Sunstar Americas, Inc. announced Oct. 27 it is voluntarily recalling a prescription oral rinse product due to a possible microbial contamination, according to the U.S. Food & Drug Administration.
The company’s ParoexChlorhexidine Gluconate Oral Rinse, 0.12% product, which is used for the treatment of gingivitis and bears an expiration date from June 30, 2022-Sept. 30, 2022, may be contaminated with the bacteria Burkholderia lata, the FDA said.
“Use of the defective product in the immunocompetent host may result in oral and, potentially, systemic infections requiring antibacterial therapy,” the FDA said in a news release.
In the most at-risk populations, the FDA added, the use of the defective product may result in life-threatening infections, such as pneumonia and bacteremia.
The recalled prescription oral rinse product, which is only available through health care professionals, is packaged as:
• 1789P GUM® Paroex® is distributed in cases each containing 6 amber bottles of 16 fluid ounce (473 ml) chlorhexidine rinse. The bottle has a childproof cap and a 15 ml metered dosage cup, is safety sealed, and is decorated with a multiple-panel wrap-around label.
• 1788P GUM® Paroex® is distributed in cases each containing 24 amber bottles of 4 fluid ounce (118.25 ml) chlorhexidine rinse. The bottle has a childproof cap, is safety sealed, and is decorated with a multiple-panel wrap-around label.
The product is distributed nationwide to dental offices, dental distributors, pharmaceutical wholesalers, dental schools and pharmacies.
According to the FDA, Sunstar is notifying its direct distributors and customers by USPS Priority mail and is arranging for return of all recalled products. Patients, pharmacies and health care facilities in possession of these products should stop using and dispensing immediately. To date, no adverse events have been reported to the company related to the recall.
Dentists with questions regarding this recall can contact Sunstar Americas, Inc. at 1-800-528-8537 or email us.pcr@us.sunstar.com from 8 a.m.-5 p.m. CT Monday-Friday.