Possible Microbial Contamination Prompts Recall of Oral Rinse

Sunstar Americas announced the voluntary recall of Paroex® Chlorhexidine Gluconate Oral Rinse USP, 0.12% due to possible contamination with the bacteria Burkholderia lata. 

The recalled products, GUM^® Paroex Chlorhexidine Gluconate Oral Rinse USP 0.12%, 473mL (NDC# 52376-021-02) and 118mL (NDC# 52376-021-04), were distributed nationwide to dental offices/distributors/schools, pharmaceutical wholesalers, and pharmacies. The recall applies to those products bearing an expiration date from 6/30/22 to 9/30/22. The full list of affected lots can be found here. 

Paroex Chlorhexidine Gluconate Oral Rinse is indicated for the treatment of gingivitis. According to Sunstar Americas, the “use of the defective product in the immunocompetent host may result in oral and, potentially, systemic infections requiring antibacterial therapy,” and may potentially result in life-threatening infections in the most at-risk populations.

To date, there have been no reported adverse events related to this recall. Consumers in possession of the affected product should discontinue use. Any adverse events associated with the recall should be reported to the FDA’s MedWatch program.

For more information regarding this recall, contact Sunstar Americas at (800) 528-8537 or email [email protected]

Reference

Sunstar Americas Inc. issues voluntary nationwide recall of Paroex® Chlorhexidine Gluconate Oral Rinse USP, 0.12% due to microbial contamination. [press release]. Chicago, IL: Sunstar Americas, Inc; October 27, 2020.