FDA expands expiration period of oral rinse recall due to possible microbial contamination

Sunstar Americas Inc. has expanded its voluntary nationwide recall on its prescription oral rinse.

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

The initial recall issued last October, stated that the affected products had expiration dates between June 30 and Sept. 30, 2022, but the FDA on Dec. 28, 2020, published an updated announcement expanding 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, used primarily for 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.

TDIC recommends the following actions if you have prescribed the oral rinse to patients:

  • Reach out to patients who were prescribed the product and inform them of the recall
  • Determine if they received the product identified in the recalled lots
  • Advise the patient(s) 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 a product replacement with a comparable product at no charge to the patient
  • Document your communication in the patient's chart

Dentists with questions about the recall can contact Sunstar Americas Inc. at 800.528.8537 or by email at [email protected] Monday-Friday from 8 a.m. to 5 p.m. CST.