Sunstar Americas is voluntarily recalling its Paroex Chlorhexidine Gluconate Oral Rinse USP 0.12% products bearing an expiration date between December 31, 2020, and September 30, 2022, due to possible contamination with the bacteria Burkholderia lata.
Use of the defective product in the immunocompetent host may result in oral and, potentially, systemic infections requiring antibacterial therapy, Sunstar said. In the most at-risk populations, use may result in life-threatening infections such as pneumonia and bacteremia.
To date, Sunstar said, 29 adverse reactions have been reported related to this recall. Affected patients tested positive for B lata infections, typically found in sputum cultures while under treatment for other serious medical conditions. Use of the contaminated product on patients with pre-existing respiratory conditions, including those infected with COVID-19, is particularly unsafe.
Affected packages include 1789P GUM Paroex and 1888P GUM Paroex.
1789P GUM Paroex is distributed in cases of six amber 16-fluid-ounce (473 ml) bottles of chlorhexidine rinse. The bottle has a childproof cap and a 15-ml metered dosage cup. It is safety-sealed and decorated with a multiple-panel wraparound label.
1788P GUM Paroex is distributed in cases of 14 amber 4-fluid-ounce (118.25 ml) bottles of chlorhexidine rinse. The bottle has a childproof cap and is safety-sealed and decorated with a multiple-panel wraparound label.
Available through healthcare professionals only, the prescription oral rinse product is indicated for use as part of a professional program for the treatment of gingivitis. It has been distributed nationwide to dental offices, distributors, pharmaceutical wholesalers, dental schools, and pharmacies.
Sunstar is notifying its direct distributors and customers by USPS Priority mail and is arranging for the return of all recalled products. Facilities in possession of these products should stop using and dispensing them immediately, the company said. For more information, Sunstar may be reached at (800) 528-8537 or us.pcr@us.sunstar.com.
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