The recall applies to the company’s Paroex Chlorhexidine Gluconate Oral Rinse USP 0.12% products which may be contaminated with the bacteria Burkholderia lata.
Sunstar Americas issued a voluntary recall of its Paroex Chlorhexidine Gluconate Oral Rinse USP 0.12% products bearing an expiration date from 6/30/22 to 9/30/22 to the consumer level. The rinse may be contaminated with the bacteria Burkholderia lata.
According to the company, use of the defective product in the immunocompetent host may result in oral and, potentially, systemic infections requiring antibacterial therapy. In the most at-risk populations, the use of the defective product may result in life-threatening infections, such as pneumonia and bacteremia. To date, no adverse events have been reported to Sunstar Americas related to this recall.
The products impacted include 1789C GUM Paroex and 1788 GUM Paroex. The first is distributed in cases each containing six 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. The second 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.
Paroex was reportedly distributed to dental offices, dental distributors, pharmaceutical wholesalers, dental schools, and pharmacies.
Sunstar Americas is notifying its direct distributors and is arranging for return of all recalled products. Patients, pharmacies, and healthcare facilities in possession of these products are advised to stop using and dispensing immediately.
A full list of affected lot numbers is available through the U.S. Food and Drug Administration website.
