Contains dangerous bacteria: FDA recalls popular mouthwashes
The US Food and Drug Administration (FDA) has announced the recall of a popular mouthwash. It can contain harmful bacteria. BestLifeOnline reported in more detail.
Photo: Shutterstock
GUM Paroex Chlorhexidine Gluconate Oral Rinse USP Mouthwash, 0,12%, available from Sunstar Americas, Inc. (SAI). GUM Paroex is distributed nationwide through dental offices, pharmacies and pharmaceutical wholesalers. The fluid is prescribed to patients with gingivitis and is available by prescription.
The recalled mouthwashes are in an amber-colored bottle and are labeled 1789P (473 ml bottle) and 1788P (118,25 ml bottle). The expiration date for the mouthwash in question is from December 31, 2020 to September 30, 2022.
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The mouthwash is especially dangerous for people with weakened immune systems.
The danger is that GUM Paroex mouthwash can be contaminated with the bacteria Burkholderia lata, which, if consumed by an immunocompromised person, can cause oral infections requiring antibiotic therapy.
Among particularly vulnerable patients, there is an additional risk of potentially fatal infections such as pneumonia and bacteremia. According to an FDA report, there have been 29 reported adverse reactions to mouthwash to date. This is especially dangerous for COVID-19 patients.
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“Use of the contaminated mouthwash by patients with pre-existing respiratory conditions, including those infected with COVID-19, is particularly hazardous,” the company noted in its recall notice.
The FDA recommends that you stop using your mouthwash immediately.
According to the FDA, "Patients, pharmacies and healthcare facilities that have these products should immediately stop using and selling these mouthwash." Patients should also contact their doctor if they experience any side effects.
SAI is currently notifying its customers of the revocation.
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