The Food and Drug Administration has announced that Sunstar Americas, Inc. has expanded their recall of Paroex Chlorhexidine Gluconate Oral Rinse USP, 0.12% due to contamination from the bacteria Burkholderia lata. The oral rinse was available by prescription, through healthcare professionals only, as part of a professional program for the treatment of gingivitis. The use of the defective product may result in oral and potentially systematic infections requiring antibacterial therapy. The use of the product on those with respiratory conditions, including those infected with Covid-19, is particularly unsafe. In the most at-risk patients, the use of the product could result in infections like pneumonia and bacteremia.
Paroex was distributed nationwide to Dental Offices, Dental distributors, Pharmaceutical wholesalers, Dental schools, and Pharmacies. Dr. Gary Cash’s office however, has not prescribed and does not use or recommend this product. Sunstar Americas, Inc. is notifying direct customers by USPS priority mail and arranging for the return of all recalled products. The FDA recommends that all those in possession of these products should stop using and dispensing immediately. Patients should contact their dentist or healthcare provider if they have experienced any problems that may be related to Paroex. If you have experienced any adverse events or side effects, you are also urged to report them to the FDA’s MedWatch 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.
View the full FDA recall notice here.