Paroex Oral Rinse Lawsuit | 2025 Latest Updates

If you or a loved one experienced bacterial infections, respiratory complications, or other serious health issues following the use of contaminated Paroex Chlorhexidine Gluconate Oral Rinse, you may be entitled to pursue compensation.

At Schmidt & Clark, LLP, we are dedicated to helping individuals who have suffered due to dangerous contaminated products.

Our experienced legal team is here to guide you through the process and fight for the compensation you deserve. Contact Schmidt & Clark, LLP today for a free, no-obligation consultation.

Paroex Oral Rinse Lawsuit Overview

Paroex Oral Rinse lawsuits center on claims that the manufacturer, Sunstar Americas, Inc., distributed contaminated oral rinse products that caused serious bacterial infections in users.

These lawsuits allege that the Paroex Chlorhexidine Gluconate Oral Rinse USP 0.12% was contaminated with Burkholderia lata, a dangerous bacterium that can cause severe infections, particularly in vulnerable individuals.

According to the FDA, at least 29 adverse events have been linked to the recalled oral rinse, with affected patients testing positive for Burkholderia lata infections.

The FDA has specifically warned that the use of contaminated products is particularly dangerous for patients with pre-existing respiratory conditions, including those infected with COVID-19.

Latest Paroex Oral Rinse Lawsuit Updates

December 28, 2020

– Sunstar Americas, Inc. expanded its recall of Paroex Chlorhexidine Gluconate Oral Rinse USP 0.12% to include products bearing expiration dates from 12/31/2020 – 9/30/2022 due to potential contamination with Burkholderia lata. The FDA reported that 29 adverse events had been linked to the recalled oral rinse, with affected patients testing positive for Burkholderia lata infections [1].

October 28, 2020 – Sunstar Americas, Inc. initiated the original recall of Paroex Gluconate USP, 0.12% products with expiration dates between 6/30/22 and 9/30/22 to the consumer level. The FDA warned that use of the defective product could result in oral and potentially systemic infections requiring antibacterial therapy, with the most at-risk populations facing potentially life-threatening infections such as pneumonia and bacteremia [2].

Use of the defective product with corresponding expiration dates in the immunocompetent host may result in oral and, potentially, systemic infections requiring antibacterial therapy. In the most at-risk populations, the use of the defective product may result in life-threatening infections, such as pneumonia and bacteremia.- ” –The U.S. Food and Drug Administration

FDA Reports and Statistics

The U.S. Food and Drug Administration has released significant data regarding the Paroex Oral Rinse contamination:

• 29 confirmed adverse events linked to the use of contaminated Paroex Oral Rinse as of December 2020
• All affected patients tested positive for Burkholderia lata infections, typically found in sputum cultures while under treatment for other serious medical conditions
• The FDA specifically warned that patients with pre-existing respiratory conditions, including those with COVID-19, face heightened risks when using the contaminated product
• Two product configurations were affected by the recall:
  • 1789P GUM® Paroex® 16 fluid ounce (473 ml) amber bottles with childproof caps and 15 ml metered dosage cups
  • 1788P GUM® Paroex® 4 fluid ounce (118.25 ml) amber bottles
• The recall expanded to include all products with expiration dates between 12/31/2020 and 9/30/2022

“To date, 29 adverse events have been linked to recalled oral rinse. Affected patients tested positive for Burkholderia lata infections, typically found in sputum cultures while under treatment for other serious medical conditions. Use of the contaminated product on patients with pre-existing respiratory conditions, including those infected with Covid-19, is particularly unsafe.- The U.S. Food and Drug Administration.

This is an expansion of the recall initially announced on Oct. 27, 2020.

If you were prescribed any Paroex that is affected by this recall, you 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,” FDA said.

This recall began on October 28, 2020.

Paroex Oral Rinse Injuries & Side Effects

The contamination of Paroex Oral Rinse with Burkholderia lata bacteria can lead to a range of serious infections and health complications, particularly in vulnerable individuals.

• Oral Infections: Localized infections in the mouth, gums, and throat requiring antibacterial treatment
• Respiratory Infections: Including pneumonia, which can be life-threatening, especially in individuals with pre-existing respiratory conditions
• Bacteremia: Bacterial infection in the bloodstream that can lead to sepsis and organ failure
• Systemic Infections: Spread of infection throughout the body, potentially affecting multiple organs
• Compromised Immune Response: Worsened health outcomes for patients with already weakened immune systems
• COVID-19 Complications: Increased risk of serious complications for COVID-19 patients exposed to the contaminated rinse

Do You Qualify for a Paroex Oral Rinse Lawsuit?

You may qualify for a Paroex Oral Rinse lawsuit if:

• You used Paroex Chlorhexidine Gluconate Oral Rinse USP 0.12% with expiration dates between 12/31/2020 and 9/30/2022
• You developed a bacterial infection, particularly with Burkholderia lata, after using the product
• You required medical treatment, including antibacterial therapy, for infections following use of the product
• You were hospitalized due to infections potentially linked to the contaminated oral rinse
• You had pre-existing respiratory conditions or were diagnosed with COVID-19 and experienced complications after using the product
• You can provide documentation of your purchase and use of the recalled Paroex Oral Rinse

Evidence Required for a Paroex Oral Rinse Lawsuit

Building a strong case requires substantial documentation of both your use of the product and the resulting health issues:

• Proof of purchase or prescription for Paroex Oral Rinse with affected lot numbers or expiration dates
• Medical records documenting bacterial infections, particularly Burkholderia lata infections
• Laboratory test results confirming the presence of Burkholderia lata bacteria
• Records of hospitalization or antibacterial treatments related to infections
• Documentation of pre-existing conditions that may have increased your risk
• Medical opinions linking your infections to the contaminated product
• Evidence of ongoing health issues resulting from the infections

Damages You Can Recover

If successful in your Paroex Oral Rinse lawsuit, you may be eligible to recover compensation for various damages, including:

• Medical expenses for treating infections and related complications
• Hospitalization costs and expenses for antibacterial therapy
• Lost wages due to time missed from work while recovering
• Pain and suffering caused by infections and treatments
• Permanent health effects or disabilities resulting from infections
• Reduced quality of life due to ongoing health issues
• Punitive damages if the manufacturer is found to have been grossly negligent

Paroex Oral Rinse Recall Information

The Paroex Oral Rinse recall includes significant details that are important for consumers and potential plaintiffs to understand:

• Initial Recall Date: October 28, 2020
• Expanded Recall Date: December 28, 2020
• Products Affected: Paroex Chlorhexidine Gluconate Oral Rinse USP 0.12%
• Expiration Dates: All products with expiration dates from 12/31/2020 – 9/30/2022
• Reason for Recall: Potential contamination with Burkholderia lata bacteria
• Recall Classification: Class I (the most serious type of recall, indicating a reasonable probability that use of the product will cause serious adverse health consequences or death)
• Distribution: Nationwide to dental offices, dental distributors, pharmaceutical wholesalers, dental schools, and pharmacies
• Manufacturer Response: Sunstar Americas, Inc. notified direct distributors and customers by USPS Priority mail and arranged for return of all recalled products

Statute of Limitations for Paroex Oral Rinse Lawsuits

The statute of limitations for filing a Paroex Oral Rinse lawsuit varies by state, typically ranging from 1-6 years from the date when the injury was discovered or should have been discovered.

Some important considerations include:

• Most states allow 2-3 years from the date of injury or discovery of injury to file a product liability claim
• The “discovery rule” may apply, meaning the statute of limitations begins when you discovered (or reasonably should have discovered) that your injury was caused by the contaminated product
• Some states have different timeframes for product liability claims versus general personal injury claims
• In cases involving bacterial infections, the onset of symptoms may be gradual, potentially complicating the determination of when the statute of limitations begins

It’s crucial to consult with an attorney as soon as possible after discovering an infection or health issue potentially related to Paroex Oral Rinse to ensure your claim is filed within the applicable deadline.

Related Article: Oral Rinse Recalled for Burkholderia Lata Contamination

FAQs

1. Can I file a lawsuit if I have already received a refund for Paroex Oral Rinse?

Yes, receiving a refund does not prevent you from seeking additional compensation for any harm or damages caused by the contaminated product.

2. What compensation can be sought in a Paroex Oral Rinse Lawsuit?

Victims can seek compensation for medical expenses, lost wages, pain and suffering, and other related damages resulting from using the contaminated product.

3. What steps are being taken to address the contamination issue with Paroex Oral Rinse?

The manufacturer is likely working with health authorities to investigate the contamination and implementing measures to ensure product safety.

4. How do I know if I used a contaminated batch of Paroex Oral Rinse?

Check the expiration date on your product. If it falls between 12/31/2020 and 9/30/2022, it is part of the recall. You can also contact your dentist, pharmacy, or the manufacturer directly to confirm if your product was affected.

5. What is Burkholderia lata and why is it dangerous?

Burkholderia lata is a type of bacteria that can cause serious infections, particularly in people with weakened immune systems or respiratory conditions. Infections may include pneumonia, bacteremia (blood infections), and other systemic infections that can be life-threatening.

6. How long after using contaminated Paroex Oral Rinse might symptoms appear?

Symptoms of infection can appear within days to weeks after using contaminated products. The timeline varies depending on the individual’s immune system, the concentration of bacteria, and other health factors.

See the other product liability claims we’re currently accepting.

Take Action Now: Time-Sensitive Legal Claims

Time is limited to pursue legal action for health issues caused by contaminated Paroex Oral Rinse. Most states have statutes of limitations ranging from 1-6 years, after which you may be permanently barred from seeking compensation for your injuries.

At Schmidt & Clark, LLP, we offer:

• Free, confidential case evaluations to determine your eligibility for a Paroex Oral Rinse lawsuit
• No upfront costs or fees to begin your case
• Payment only if we win your case – you pay nothing unless we recover compensation for you
• Experienced product liability attorneys who understand the complexities of bacterial contamination cases

If you’ve suffered infections or health complications after using Paroex Oral Rinse, contact our experienced attorneys today to learn about your legal options and how we can help you seek justice and compensation.

References

1. https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/sunstar-americas-inc-expands-voluntary-nationwide-recall-paroexr-chlorhexidine-gluconate-oral-rinse
2. https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/sunstar-americas-inc-issues-voluntary-nationwide-recall-paroexr-chlorhexidine-gluconate-oral-rinse