the Food and Drug Administration (FDA) of United States alert the population about a contaminated mouthwash with a bacteria which can be potentially dangerous to health.
After the alert of the FDA, The company Sunstar Americas Inc. began to withdraw the Paroex GUM rinse of the market.
The health agency detected that a batch of product is contaminated with the bacterium Summer Burkholderia, Which can severely affect people with weak immune systems or chronic lung disease, according to the Centers for Disease Control and Prevention (CDC).
the CDC they need this bacteria it may be resistant to common antibiotics, so you should seek medical attention to treat each particular case.
the Food and Drug Administration announced a first retirement last October 27, but this week extended the alert. Since that warning, the agency has recorded 29 adverse events from people who tested positive for it infection per Summer Burkholderia.
The use of Paroex mouthwash can cause “oral infections” that require treatment antibacterial“, Specified the FDA in a statement. In addition, this product may be unsafe in patients with Covid-19.
Lots with pollution warning have an expiration date of December 31, 2020 on September 30, 2022 and are sold in the following submissions:
– Boxes with six 16-ounce bottles of GUM Paroex.
– Boxes with 24 bottles of four ounces of GUM Paroex.
Sunstar Americas Inc. expands voluntary nationwide withdrawal of Paroex USP chlorhexidine oral glucose wash, 0.12% due to microbial contamination https://t.co/vQJHkUdoGA pic.twitter.com/OUqRahSUt3
– US FDA Recalls (@FDArecalls) December 29, 2020
The company Sunstar Americas distributed the mouthwash in different regions of the United States to dental offices, dental distributors, pharmacies, dental schools, and pharmaceutical wholesalers.
The recommendation of the FDA is that patients and health centers should stop using the product immediately and contact a doctor if they show symptoms of infection due to Summer Burkholderia.
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