FDA MedWatch - Paroex (chlorhexidine gluconate) Oral Rinse by Sunstar Americas: Recall - Due to Microbial Contamination

MedWatch - The FDA Safety Information and Adverse Event Reporting Program TOPIC: Paroex (chlorhexidine gluconate) Oral Rinse by Sunstar Americas: Recall - Due to Microbial Contamination AUDIENCE: Patient, Health Professional, Pharmacy, Dentistry ISSUE: Sunstar Americas, Inc. (SAI) is recalling Paroex (chlorhexidine gluconate) Oral Rinse USP, 0.12% products with an expiration date of 6/30/22 – 9/30/22 because this product may be contaminated with the bacteria Burkholderia lata. Use of this 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. BACKGROUND: This prescription oral rinse product available through healthcare professionals only, is indicated for use as part of a professional program for the treatment of gingivitis. For more information about the affected products, including lot numbers and product photos, please click red button "Read Recall" below. 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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