Product Recall: Chlorhexidine Gluconate Oral Rinse USP, 0.12%

 

To: All providers From: CDPHE Sunstar Americas, Inc. (SAI) is voluntarily recalling Paroex® Chlorhexidine Gluconate Oral Rinse USP, 0.12% products with an expiration date from 6/30/22 – 9/30/22 and specific lot numbers to the consumer level. 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 as pneumonia and bacteremia. To date, no adverse events have been reported to SAI related to this recall. Paroex was distributed nationwide to dental offices, dental distributors, pharmaceutical wholesalers, dental schools, and pharmacies. SAI is notifying its direct distributors and customers by USPS Priority mail and is arranging for return of all recalled products. Patients, pharmacies, and healthcare facilities in possession of these products should stop using and dispensing immediately. Affected products and lot numbers can be found on the U.S. Food and Drug Administration’s (FDA’s) website, along with contact information for questions regarding this recall, and how to report adverse reactions: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/sunstar-americas-inc-issues-voluntary-nationwide-recall-paroexr-chlorhexidine-gluconate-oral-rinse