Prescription Oral Rinse Recalled Nationwide Over Possible Bacteria Contamination

The U.S. Food and Drug Administration (FDA) this week announced that Sunstar Americas Inc. (SAI) is issuing a nationwide voluntary recall of Paroex® Chlorhexidine Gluconate Oral Rinse USP, 0.12% due to a possible contamination of the Burkholderia lata bacteria.

The company noted the possibility of oral or systemic infections following the use of the product, adding that people considered to be "at risk" may experience "life-threatening" infections including bacteremia and pneumonia.

The FDA did not specify how the products being recalled may have been contaminated but, as of the Oct. 27 announcement, no "adverse effects" related to the recall have been reported.

Burkholderia lata is part of group K of the Burkholderia cepacia complex (bcc), which is comprised of at least nine species that are considered to be among the most metabolically versatile known microorganisms, the Universal Protein Resource (UniProt) said. Although involved in pollutant biodegradation, they can also cause diseases in plants, animals, and humans, particularly in the lungs of patients with chronic lung diseases.

The products affected by the recall, 1789P GUM® Paroex® and 1788P GUM® Paroex®, were distributed to dental clinics, dental schools, distributors, pharmaceutical wholesalers, and pharmacies nationwide as part of a professional treatment of gingivitis. They were only available through healthcare professionals, the recall stated, and had expiry dates from 6/30/22 to 9/30/22.

The FDA provided specific descriptions of the affected products' packaging:

• 1789P GUM® Paroex® is distributed in cases each containing 6 amber bottles of 16 fluid ounces (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 ounces (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 lot numbers of the affected products are available at the FDA website and the agency also shared images of the affected products on Twitter.

Anyone or any facility that may have purchased the affected products is advised to stop using them and dispose of them immediately. Those who experienced adverse reactions after using the product should also contact their healthcare provider.

Those who have questions about the recall may contact SAI at 1-800- 528-8537 or via email at us.pcr@us.sunstar.com.