Food and Drug Administration (FDA) of US alerted the population about a contaminated mouthwash with bacteria which can be potentially dangerous to health.
After the alert FDA, Sunstar Americas Inc. he began to withdraw Paroex GUM rinse From the market.
The health agency has detected that much of product this contaminate with bacteria Vara Burkholderia, which can seriously affect people with weak immune systems or chronic lung disease, according to the Centers for Disease Control and Prevention (CDC).
CDC they need that bacteria it may be resistant to regular antibiotics, so medical attention should be sought to consider each particular case.
Food and Drug Administration announced a first recall on October 27 last year, but this week has been extended alert. Since that notification, the agency has recorded 29 adverse events from people who tested positive infection of Vara Burkholderia.
The use of Paroex mouthwash can cause oral infections “that require treatment ANTIBACTERIAL“, He specified FDA it is a statement. In addition, this product may be unsafe in patients with Covid-19.
Lots with a warning of contamination expire between 31 December 2020 and 30 September 2022 and are sold in the following presentations:
– Boxes of six 16-ounce bottles GUM Paroex.
– Boxes of 24 four ounce bottles GUM Paroex.
Sunstar Americas Inc. extends voluntary nationwide withdrawal of oral rinsing Chlorhexidine gluconate Paroex USP, 0.12% due to microbial contamination https://t.co/vQJHkUdoGA pic.twitter.com/OUqRahSUt3
– US FDA Recalls (@FDArecalls) December 29, 2020
Sunstar Americas Company distributed mouthwash in various parts of the United States to dental offices, dental distributors, pharmacies, dental schools, and pharmaceutical wholesalers.
recommendation FDA is that patients and health centers should stop using the product immediately and contact a doctor if they show symptoms of infection until Vara Burkholderia.
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