Update: GUM Paroex Recall Expanded for Burkholderia lata Contamination
The FDA on 12/28/20 announced that Sunstar Americas, Inc. has expanded its recall for Paroex Chlorhexidine Gluconate Oral Rinse USP, 0.12% products bearing an expiration date from 12/31/2020 – 9/30/2022 over potential contamination with Burkholderia lata. At least 29 adverse events have been associated with this recall to date.
“Affected patients tested positive for Burkholderia lata infections, typically found in sputum cultures while under treatment for other serious medical conditions,” FDA said. “Use of the contaminated product on patients with pre-existing respiratory conditions, including those infected with Covid-19, is particularly unsafe.”
What’s the Problem?
This FDA Recall began on October 29, 2020, and affects Paroex Chlorhexidine Gluconate Oral Rinse USP, 0.12% products with expiration dates between 6/30/22 and 9/30/22 to the consumer level.
The use of contaminated Paroex oral rinse may result in the following injuries (which could require antibacterial therapy to treat):
- Oral infections
- Systemic infections
- Pneumonia
- Bacteremia
- And more
The recalled oral rinse was distributed nationwide by Sunstar Americas, Inc., to dental offices, dental distributors, pharmaceutical wholesalers, dental schools, and pharmacies.
Consumers were prescribed any recalled Paroex oral rinse should stop using it immediately. SAI is notifying its direct distributors and customers by USPS Priority mail and is arranging for return of all recalled products.
Do I Have a Paroex Class Action Lawsuit?
The Class Action Litigation Group at our law firm is an experienced team of trial lawyers that focus on the representation of plaintiffs in Paroex Lawsuits. We are handling individual litigation nationwide and currently accepting new cases in all 50 states.
If you or a loved one was injured by recalled oral rinse, you should contact our law firm immediately. You may be entitled to a settlement by filing a suit and we can help.