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FDA issues recall alert on prescription oral rinse due to possible contamination

November 23, 2020 2772

Quick Summary:

A prescription oral rinse, distributed nationwide to dental offices, dental distributors, pharmaceutical wholesalers, dental schools and pharmacies, has been recalled due to a possible microbial contamination.

Sunstar Americas, Inc. on Oct. 27 voluntarily recalled its prescription oral rinse due to a possible microbial contamination.

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

The oral rinse, used primarily for treatment of gingivitis, has an expiration date between June 30, 2022, and Sept. 30, 2022.

The product 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.

To date, no adverse events have been reported to the company related to the recall.

Dentists with questions about the recall can contact Sunstar Americas, Inc. at 800.528.8537 or by email us.pcr@us.sunstar.com Monday-Friday from 8 a.m. to 5 p.m. CST.