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Sunstar Americas recalls GUM brand gingivitis treatment

The product may be contaminated with Burkholderia lata

Photo
Photo source: FDA
Sunstar Americas, Inc. (SAI) is recalling GUM brand Paroex Chlorhexidine Gluconate Oral Rinse, a prescription oral rinse, used for the treatment of gingivitis.

The product may be contaminated with the bacteria Burkholderia lata. Use of the contaminated product on patients with pre-existing respiratory conditions -- including those infected with Covid-19 -- is particularly unsafe.

Twenty-nine adverse events have been reported to date.

The following products are being recalled:

  • 1789P GUM Paroex in cases 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 wrap-around label with an expiration date from December 31, 2020, through September 30, 2022.
  • 1788P GUM Paroex in cases 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 with an expiration date from December 31, 2020, through September 30, 2022.

The recalled product was shipped nationwide to dental offices, dental distributors, pharmaceutical wholesalers, dental schools and pharmacies.

What to do

SAI is notifying its direct distributors and customers by USPS Priority mail and is arranging for return of all recalled products. Consumers should stop using the recalled product immediately and contact their physician or healthcare provider if they have had any problems.

Consumers with questions may contact SAI at (800) 528-8537 Monday – Friday from 8am – 5pm (CST), or by email us.pcr@us.sunstar.com.

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