Sunstar Americas Expands Paroex Recall

FDA says Sunstar Americas has expanded its nationwide recall of Paroex chlorhexidine gluconate oral rinse 0.12% due to microbial contamination. The expanded recall covers products bearing an expiration date from 12/31/20 to 9/30/22, according to an agency notice. The notice says the product may be contaminated with the bacteria Burkholderia lata.

To date, 29 adverse events have been reported to the company related to the recall, the agency says. “Affected patients tested positive for Burkholderia lata infections, typically found in sputum cultures while under treatment for other serious medical conditions,” the notice says. “Use of the contaminated product on patients with pre-existing respiratory conditions, including those infected with Covid-19, is particularly unsafe.”

The company says Paroex was distributed nationwide to dental offices, dental distributors, pharmaceutical wholesalers, dental schools, and pharmacies.