Lohxa LLC recalled certain lots of germicidal mouthwash Chlorhexidine Gluconate Oral Rinse USP, 0.12% due to potential microbial contamination, the U.S. Food and Drug Administration said in a statement.
The pharmaceutical repackaging company is calling back five lots of Chlorhexidine Gluconate Oral Rinse USP, 0.12% alcohol free that are packaged in cases each containing 50 units of 15-ml dose cups, with expiration dates between January 31, 2021 and March 31, 2021.
According to the company, the product is sourced from and repackaged by Sunstar Americas Inc. who notified that the product may be contaminated with the bacteria Burkholderia lata.
The use of the product can cause oral and, potentially, systemic infections requiring antibacterial therapy. It may also result in life-threatening infections, such as pneumonia and bacteremia, in the most at-risk populations.
However, Lohxa said no adverse events have been reported to date involving the recalled product.
Chlorhexidine gluconate is a germicidal mouthwash that reduces bacteria in the mouth. It is used to treat a mild form of gum disease called gingivitis that causes swelling, redness and bleeding gums and is usually prescribed by a dentist.
The prescription oral rinse product is indicated for the treatment of gingivitis. It is available through institutional use only and was distributed to hospital pharmacies across the U.S.
Lohxa urged patients, pharmacies, and healthcare facilities in possession of these products to immediately stop using them. It is arranging for return of all recalled products, the company added.
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