Using the recalled product may cause oral or systemic infections requiring antibacterial therapy, the company said. The drug may contain Burkholderia lata, which in at-risk populations may cause life-threatening infections such as pneumonia and bacteremia. No adverse events have been reported, Sunstar said.
The prescription oral rinse is designed to treat gingivitis and has been distributed nationwide to dental offices, dental distributors, pharmaceutical wholesalers, dental schools and pharmacies.
Sunstar said it is notifying its distributors and customers by U.S. Postal Service priority mail and arranging for all affected products to be returned. Patients, pharmacies and healthcare facilities should stop using and dispensing the drug immediately, the company said.
Read the full news release here.
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