FDA MedWatch - Paroex Chlorhexidine Gluconate Oral Rinse USP, 0.12% by Sunstar Americas: Recall - Due to Microbial Contamination

MedWatch - The FDA Safety Information and Adverse Event Reporting Program TOPIC: Paroex Chlorhexidine Gluconate Oral Rinse USP, 0.12% by Sunstar Americas: Recall - Due to Microbial Contamination AUDIENCE: Patient, Health Professional, Pharmacy ISSUE: Sunstar Americas is recalling Paroex Chlorhexidine Gluconate Oral Rinse USP, 0.12% products bearing an expiration date from 12/31/2020 – 9/30/2022. This product may be contaminated with the bacteria Burkholderia lata. This is an expansion of the recall initially announced on October 27, 2020. 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, 29 adverse events have been reported to Sunstar Americas related to this recall. 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. For product pictures and more information about this recall click on red button "Read Recall" below. BACKGROUND: 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.  RECOMMENDATION: Patients, pharmacies, and healthcare facilities in possession of these products should stop using and dispensing immediately. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to using this drug product. Health professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program: Complete and submit the report online. Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on form, or submit by fax to 1-800-FDA-0178.

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