Paroex Chlorhexidine Gluconate Oral Rinse Recalled Due to Risk of Bacterial Infection
UNITED STATES – According to ADA.ORG and FDA.GOV, Sunstar Americas, Inc. (SAI) is issuing a voluntary recall of a prescription oral rinse product due to the risk of microbial contamination, per the United States Food & Drug Administration (FDA).
The manufacturer’s Paroex Chlorhexidine Gluconate Oral Rinse (0.12% product), used to treat gingivitis that has an expiration date from 6/30/22 to 9/30/33, may be contaminated by Burkholderia lata, a dangerous bacteria that can cause serious illness and even death, per the FDA.
According to the FDA, “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.”
As of today, there have been no reports of illness or death to SAI that is associated with the use of the product.
The oral rinse product that has been recalled, which is only available to consumers through a prescription, is as follows:
1789P GUM® Paroex® is distributed in cases, each containing 6 amber bottles of 16 fluid ounce (473 ml) chlorhexidine rinse. The bottle has a childproof cap and a 15 ml metered dosage cup, is safety sealed, and is decorated with a multiple-panel wrap-around label.
1788P GUM® Paroex® is distributed in cases, each containing 24 amber bottles of 4 fluid ounce (118.25 ml) chlorhexidine rinse. The bottle has a childproof cap, is safety sealed, and is decorated with a multiple-panel wrap-around label.
It is important to note that the product is distributed throughout the United States to dental distributors, dental offices, dental schools, pharmacies, and wholesalers.
Per the FDA, SAI is issuing a notice to customers and direct distributors by USPS Priority Mail and is seeking to arrange the return of all of the affected products. Those in possession of the product must discard it immediately.
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Sources:
https://www.ada.org/en/publications/ada-news/2020-archive/november/prescription-oral-rinse-product-recalled-due-to-microbial-contamination#:~:text=The%20company's%20ParoexChlorhexidine%20Gluconate%20Oral,Burkholderia%20lata%2C%20the%20FDA%20said.
https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/sunstar-americas-inc-issues-voluntary-nationwide-recall-paroexr-chlorhexidine-gluconate-oral-rinse