Sunstar Americas is expanding its recall for its gingivitis oral rinse, paroex chlorhexidine gluconate, because it may contain the bacteria Burkholderia lata.
The recall, initially announced Oct. 27, has been expanded to include all its gingivitis oral rinses expiring between Dec. 31, 2020, and Sept. 30, 2022.
Use of the defective product may result in oral and potentially systemic infections requiring antibacterial therapy, according to the company’s Dec. 28 news release. In high-risk populations, use of the defective product may result in life-threatening infections.
To date, 29 adverse events related to this recall have been reported.
Healthcare professionals should stop using the product immediately.