What's the Problem?
This recall affects Chlorhexidine Gluconate Oral Rinse USP, 0.12% Alcohol-free (NDC:70166-027-15) products bearing an expiration date from 01/31/21 – 03/31/21 to the consumer level, according to the U.S. Food & Drug Administration (FDA) [1]. Affected lot numbers include:
- T09101A -- Expiration Date 01/2021
- T08292A -- Expiration Date 02/2021
- T10011A -- Expiration Date 02/2021
- M10193A -- Expiration Date 03/2021
- T10223A -- Expiration Date 03/2021
"Use of the defective product in the immunocompetent host may result in oral and, potentially, systemic infections requiring antibacterial therapy," FDA said. "In the most at-risk populations, the use of the defective product may result in life-threatening infections, such as pneumonia and bacteremia."
The recalled oral rinse was sourced and repackaged from Sunstar Americas Inc., who notified Lohxa LLC that the product may be contaminated with Burkholderia lata. Chlorhexidine Gluconate Oral Rinse is available through institutional use only, and used as part of a professional program for the treatment of gingivitis.
This recall began on November 9, 2020.
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Do I Have an Oral Rinse Lawsuit?
The Pharmaceutical Litigation Group at our law firm is an experienced team of trial lawyers that focus on the representation of plaintiffs in Oral Rinse 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.
