The United States Food and Drug Administration (FDA) alerted consumers to the use of mouthwash Paroex GUM .
According to the report this product may be contaminated with the bacterium Burkholderia lata , which is dangerous for patients who present pre-existing respiratory conditions , including those with Covid – 19 .
The use of the defective product in a person immunocompetent can cause oral and potentially systemic infections that require antibacterial treatment . In higher-risk populations, the use of the defective product can cause life-threatening infections , such as pneumonia and bacteremia.
“The use of contaminated product in patients with pre-existing respiratory conditions, including those infected with covid – 19 , is particularly unsafe “, says the statement .
The prescription mouthwash product , available only through healthcare professionals, is indicated for use as part of a program professional for the treatment of gingivitis .
Sunstar Americas Inc. Expands Voluntary Nationwide Recall of Paroex® Chlorhexidine Gluconate Oral Rinse USP, 0. 12% Due to Microbial Contamination https://t.co/vQJHkUdoGA pic.twitter.com/ OUqRahSUt3
– US FDA Recalls (@FDArecalls) December 29, 2020
The recommendation of the FDA is that patients and health centers leave to use the product of immediate and to contact a doctor if they show symptoms of infection by Burkholderia lata .
The agency reported that the items voluntarily withdrawn are those with an expiration date of 12 / 31 / 2020 to 9 / 30 / 2022 , and are sold in the following presentations:
Boxes with six bottles of 16 ounces of GUM Paroex .
And boxes with 24 bottles of four ounces of GUM Paroex .
After the FDA alert, the company Sunstar Americas Inc. began to withdraw the GUM Paroex rinse from the market.
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