FDA MedWatch - Paroex Chlorhexidine Gluconate Oral Rinse USP, 0.12% by Precision Dose: 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 Precision Dose: Recall - Due to Microbial Contamination AUDIENCE: Patient, Health Professional, Pharmacy ISSUE: Precision Dose is recalling all lots of Chlorhexidine Gluconate Oral Rinse USP, 0.12%, 15mL Unit Dose Cups with an expiration date from 1/31/2021 – 02/28/2022. Precision Dose was notified by the manufacturer of the product, Sunstar Americas, that this 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 pneumonia and bacteremia. To date, no adverse events have been reported to Precision Dose related to this recall. For more information about the affected products and lot numbers related to 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 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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