Drug Safety Alerts

Paroex® Chlorhexidine Gluconate Oral Rinse USP, 0.12% Expanded Consumer-Level Recall

12/28/2020

On December 28, 2020, Sunstar Americas, Inc. (SAI) issued a consumer-level recall of Paroex® Chlorhexidine Gluconate Oral Rinse USP, 0.12%. This recall was issued because the product may be contaminated with the bacteria Burkholderia lata.

This is an expansion of the recall initially announced on October 27, 2020.

A complete list of the affected products and lot numbers can be found here.

According to SAI, use of the defective product in the immunocompetent host may result in oral and, potentially, systemic infections requiring antibacterial therapy, and 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, 29 adverse events have been reported to SAI related to this recall. According to SAI, affected patients tested positive for Burkholderia 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.

The prescription oral rinse product, available through healthcare professionals only, is indicated for use as part of a professional program for the treatment of gingivitis and is packaged as follows:

• 1789P GUM® Paroex® is distributed in cases each containing 6 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.

• 1788P GUM® Paroex® 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.

This may represent a health hazard or safety risk to patients using product affected by this recall.

SAI advises that patients should stop using their Paroex® Chlorhexidine Gluconate Oral Rinse USP, 0.12% immediately. Patients should call their healthcare provider further guidance and/or a replacement prescription.

CVS Caremark Response: Because of this action, CVS Caremark® is sending letters to members who received this product through CVS Caremark® Mail Service Pharmacy and their physicians

For more information about this recall, please call SAI at 1-800-528-8537, Monday through Friday from 8:00 AM to 5:00 PM (CST). You may also call the U.S. Food and Drug Administration (FDA) consumer inquiry line at 1-888-INFO-FDA (1-888-463-6332) or visit www.fda.gov.