Sunstar Americas, Inc. (SAI) voluntarily recalled more of its Paroex Chlorhexidine Gluconate Oral Rinse after 29 people reported being exposed to bacterial contamination. This is an expansion to the first recall the company has announced.
Sunstar first issued a voluntary nationwide recall of the product on October 27, 2020 to the consumer level. The company reported that the product might be contaminated with the bacteria Burkholderia lata.
This contamination, of course, could lead to a wide array of side effects that are harmful to people. If the claims in the Paragard lawsuits have side effects ranging from the mildest to the worst, this defective product is no different, as adverse reactions from the recalled mouthwash can also cause life-threatening conditions.
Possible Side Effects of the Contaminated Mouthwash
According to the company announcement made for the recall, using the defective product may cause oral and possibly systemic infections which would require antibacterial therapy.
“In the most at-risk populations,” Sunstar added, “the use of the contaminated mouthwash may result in life-threatening infections, such as pneumonia and bacteremia.”
The company also noted that the use of the contaminated product on patients with underlying respiratory problems, including people who are infected with Covid-19, is particularly unsafe.
Impacted Products
On October 27 of the previous year, the company first recalled 1-pint and 4-ounce bottles of the mouthwash that bore expiration dates between June 30, 2022 and September 30, 2022.
Now, Sunstar Americas, Inc. has expanded the recall, including all bottles with expiration dates from December 31, 2020 and September 30, 2022.
The oral rinse product was made available to dental offices, healthcare professionals, dental distributors, dental schools, pharmaceutical wholesalers, and pharmacies. The product was indicated for use as part of a professional program to treat gingivitis.
Notice to Consumers
“Patients, pharmacies, and healthcare facilities in possession of these products should stop using and dispensing immediately, said Sunstar.
Consumers with questions about the recall can contact Sunstar Americas by email at us.pcr@us.sunstar.com from Monday to Friday, during typical business hours.
Should there be any medical issues that arise from the use of the defective product, consumers should also get in touch with their physician or healthcare provider.
Adverse effects or reactions can also be reported to the MedWatch Adverse Event Reporting program of the U.S. Food and Drug Administration, through the FDA website.
Sunstar Americas has already notified its customers and direct distributors and has already arranged for the return of all recalled products.
