The Food and Drug Administration (FDA) from U.S warned the population about one contaminated mouthwash right away bacteria that can be potentially dangerous to health.
After the warning from the FDA, Sunstar Americas Inc. the enjuague GUM Paroex From the market.
The health service found that many of the Product this contaminated with the bacteria Burkholderia summer, which can have serious consequences for 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 can be resistant to many common antibiotics, so medical attention should be sought in each individual case.
The Food and Drug Administration announced an initial recall last Oct. 27, but extended this week alert. Since that notification, the agency has recorded 29 adverse events of people who tested positive infection through Burkholderia summer.
The use of Paroex mouthwash can cause oral infections “requiring treatment antibacterial, It specified FDA it is a statement. In addition, this product may be unsafe in patients with COVID-19.
Batches with a contamination warning have an expiration date from December 31, 2020 to September 30, 2022 and are sold in the following presentations:
– Boxes of six 16-ounce bottles GUM Paroex.
– Boxes of 24 bottles of 120 ml GUM Paroex.
Sunstar Americas Inc. extends voluntary national 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
Sunstar Americas Company has developed the mouthwash in various 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 immediately stop using the product and contact a doctor if they show symptoms of infection due to Burkholderia summer.
p