Drug Safety Alerts

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

10/28/2020

On October 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.

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 SAI related to this recall.

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.

A complete list of the affected products and lot numbers is provided here.

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 Mail Service Pharmacy is contacting patients and prescribers to advise them of this recall. We are encouraging patients who are taking Paroex® Chlorhexidine Gluconate Oral Rinse USP, 0.12% to contact their prescriber.

For more information about the 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.