FDA expands oral rinse recall due to possible microbial contamination

An expansion of the voluntary nationwide recall on prescription oral rinse sold through Sunstar Americas Inc. calls for pharmacies and dental offices to stop using and dispensing potentially affected products immediately.

A U.S. Food and Drug Administration news release states that the company’s Paroex Chlorhexidine Gluconate Oral Rinse USP, 0.12% product could be contaminated with the bacteria Burkholderia lata and use may result in oral infections and life-threatening infections, such as pneumonia and bacteremia for the most at-risk patients.

The initial recall issued in October 2020 stated that the affected products had expiration dates between June 30 and Sept. 30, 2022; however, on Dec. 28, 2020, the FDA published an update that expanded the expiration period from Dec. 31, 2020, to Sept. 30, 2022.

To date, 29 people have tested positive for Burkholderia lata infections from using the recalled product, according to the announcement.

The oral rinse, primarily used for the treatment of gingivitis, is distributed nationwide to dental offices, dental distributors, pharmaceutical wholesalers, dental schools and pharmacies and packaged as:

• 1789PGUM® Paroex® is distributed in cases with each containing six amber bottles of 16 fluid ounce (473 ml) chlorhexidine rinse. The bottle has a childproof cap and a 15 ml metered dosage cup, is safety sealed and is decorated with a multiple-panel wraparound label.
• 1788PGUM® Paroex® is distributed in cases with each containing 24 amber bottles of 4 fluid ounce (118.25 ml) chlorhexidine rinse. The bottle has a childproof cap, is safety sealed and is decorated with a multiple-panel wrap-around label.

According to the FDA, Sunstar is notifying its direct distributors and customers by U.S. Postal Service priority mail and is arranging for the return of all recalled products. Patients, pharmacies and health care facilities that possess the products should stop using and dispensing them immediately.

The Dentists Insurance Company recommends the following actions for practices that have prescribed the oral rinse:

• Reach out to patients who were prescribed the product to inform them of the recall.
• Determine if the patient received the product identified in the recalled lots.
• Advise the patient to immediately discontinue use of the product.
• Provide patients with a copy of the recall notice.
• Agree to provide patients with any recall updates you receive.
• Consider offering to replace the product with a comparable one at no charge.
• Document your communication in the patient's chart.

Dentists who have questions about the recall may email Sunstar Americas Inc. or call 800.528.8537.

For additional dentist-centric guidance navigating potential practice issues, refer to TDIC’s Resources to Manage Your Risks.