Oral rinse recalled due to possible microbial contamination

2020 03 20 21 56 8540 Warning Circular 400

Illinois-based medical supplier Sunstar Americas has issued a voluntary U.S. recall for its chlorhexidine oral rinse, which dental patients are prescribed to treat gingivitis, due to possible microbial contamination.

Clinicians should stop prescribing and tell patients to cease using chlorhexidine gluconate oral rinse, 0.12% (Paroex) immediately because it may be contaminated with the bacteria Burkholderia lata. The recall includes 4- and 16-oz bottles of the prescription-only rinse with expiration dates between June 30, 2022, and September 30, 2022, according to a notice issued October 28 by the U.S. Food and Drug Administration (FDA).

B. contaminans and B. lata are part of the B. cepacia complex of bacteria that can be found in water and soil. The species are a major cause of pharmaceutical contamination, and B. lata has been found in chlorhexidine mouthwash in the past.

Use of this defective product by immunocompromised patients may cause oral and systemic infections, including life-threatening conditions such as pneumonia and bacteremia, according to the FDA. At this time, no adverse events related to the recall have been reported to Sunstar, the agency noted.

This notice may be especially important for clinicians who have had patients gargle with a chlorhexidine rinse prior to treatment during the pandemic. Some evidence has shown that using this type of rinse can significantly reduce viral load in the saliva of patients with COVID-19.

Paroex was distributed nationwide to dental offices, dental distributors, pharmaceutical wholesalers, dental schools, and pharmacies. Sunstar, which announced the recall on October 27, is notifying its direct distributors and customers by U.S. Postal Service Priority mail and is arranging for recalled products to be returned.

Adverse reactions or quality problems related to the product can be submitted to the FDA's MedWatch adverse event reporting program.

A full list of the products and lot numbers is available on the FDA's website.

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