The anti-gingivitis mouthwash GUM Paroex® was recalled after at least 29 people were infected with an antibiotic-resistant bacteria.
What You Can Do & How We Can Help
The Schmidt Firm, PLLC is currently accepting GUM Paroex mouthwash induced injury cases in all 50 states. If you or somebody you know has been diagnosed with an infection, you should contact our lawyers immediately for a free case consultation. Please use the form below to contact our Product Liability Litigation Group or call toll free 24 hours a day at (866) 920-0753.
UPDATE: Paroex Recall Expanded After 29 Infections Reported
On December 28, 2020, Sunstar Americas expanded a recall for GUM Paroex® gingivitis mouthwash after 29 people were infected with the bacteria Burkholderia lata, which can worsen a pre-existing COVID infection or cause other life-threatening side effects, such as pneumonia and bacteremia.
The recall now includes all lots with expiration dates ranging from 12/31/2020 through 9/30/2022, including:
- GUM Paroex® Chlorhexidine Gluconate Oral Rinse USP, 0.12%, 16 fl.oz. Amber Bottles (NDC# 052376-021-02 and Product Code 1789P)
- GUM Paroex® Chlorhexidine Gluconate Oral Rinse USP, 0.12%, 4 fl.oz. Amber Bottles (NDC# 052376-021-04 and Product Code 1788P).
Precision Dose Inc. Recalls Generic Paroex® for Infection Risk
On December 31, 2020, Precision Dose, Inc. recalled all lots of a generic Paroex® mouthwash product (Chlorhexidine Gluconate Oral Rinse USP, 0.12%, 15mL Unit Dose Cups) with expiration dates between 1/31/2021 and 02/28/2022 after being notified by Sunstar Americas, Inc. that it may be contaminated with the bacteria Burkholderia lata.
Lohxa LLC Recalls Chlorhexidine Gluconate Oral Rinse USP, 0.12%
On November 9, 2020, Lohxa, LLC recalled a generic Paroex mouthwash product, Chlorhexidine Gluconate Oral Rinse USP, 0.12% (NDC 70166-027-15) with expiration dates from 01/31/21 – 03/31/21 due to a risk of infections with the bacteria Burkholderia lata. The product was sourced and repackaged from Sunstar Americas Inc.
Original Recall for GUM Paroex
On October 27, 2020, Sunstar Americas Inc. recalled GUM Paroex® Chlorhexidine Gluconate Oral Rinse USP, 0.12% due to a risk of contamination with an antibiotic-resistant bacteria.
What is GUM Paroex?
GUM Paroex is a prescription-only mouthwash for the treatment of moderate to severe gingivitis. It is also used to manage gingival gum bleeding and inflammation between dental visits.
What is the Risk?
The recalled bottles of GUM Paroex may be contaminated with Burkholderia lata, a multi-drug resistant bacteria that can cause infections in the mouth and body.
People with gingivitis have a higher risk of developing infections due to open sores in their mouth, which provides a route for bacteria to invade the body.
The infection may spread to the body and cause a life-threatening systemic infection, pneumonia, or bacteremia (blood infection or sepsis), which would require antibiotic therapy and hospitalization.
Use of Contaminated Product Could Worsen COVID Infection
An infection with bacteria in GUM Paroex could significantly worsen an underlying COVID infection, according to the recall: “Use of the contaminated product on patients with pre-existing respiratory conditions, including those infected with Covid-19, is particularly unsafe.”
Who Is At High Risk?
High-risk people include individuals who are elderly, HIV-positive, cancer patients undergoing chemotherapy, hemodialysis patients, people with other pre-existing illnesses, or an underlying infection with COVID-19.
Do I have a GUM Paroex Lawsuit?
The Schmidt Firm, PLLC is currently accepting GUM Paroex mouthwash induced injury cases in all 50 states. If you or somebody you know has been diagnosed with an infection, you should contact our lawyers immediately for a free case consultation. Please use the form below to contact our Product Liability Litigation Group or call toll free 24 hours a day at (866) 920-0753.
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