Voluntary Recall of Paroex Chlorhexidine Gluconate Oral Rinse

January 8, 2021 Update: This article has been updated to add an additional manufacturer to the recall (Precision Dose Inc.). The original article was posted on January 4, 2021.

Sunstar Americas, Inc. has announced voluntary recalls of all lots of National Drug Codes (NDCs) for the following gum disease product: Paroex Chlorhexidine Gluconate Oral Rinse.

This product is being recalled due to concerns that the product may be contaminated with the bacteria Burkholderia lata.

Please see below for more information.

Paroex Chlorhexidine Gluconate Oral Rinse Recall Quick Reference:

Wave 1

Manufacturer: Sunstar Americas, Inc.

Recall Date: 12/28/2020

URL:https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/sunstar-americas-inc-expands-voluntary-nationwide-recall-paroexr-chlorhexidine-gluconate-oral-rinse

Wave 2

Manufacturer: Precision Dose, Inc.

Recall Date: 12/31/2020

URL:https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/precision-dose-inc-issues-voluntary-nationwide-recall-paroex-chlorhexidine-gluconate-oral-rinse-usp

Drug names are registered marks of their respective owners.

This update is for awareness purposes only. No further action is needed.