Schaumburg, Il. – Sunstar Americas, Inc. has expanded a recall of GUM Paroex Chlorhexidine Gluconate Oral Rinse USP, 0.12% products with expiration dates from December 31, 2020 through September 30, 2022 due to contamination with the bacteria Burkholderia lata.
Using the contaminated rinse may result in oral or in severe cases systemic infections requiring antibacterial therapy. In the most at-risk populations, using the product can cause life-threatening infections leading to pneumonia or bacteremia.
Currently, there have been 29 reports of infections related to the recall. Most of the infections were found in patients with other serious medical conditions.
The prescription oral rinse is used to treat gingivitis and is only available through healthcare professionals.
It is packaged in the following ways:
- Cases containing six amber bottles of 16 fluid ounce (473 mL) chlorhexidine rinse. The bottles have childproof caps and come with 15 mL dosage cups, a safety seal, and a multi-panel wrap-around label.
- Cases containing 24 amber bottles of 4 fluid ounce (118.25 mL) chlorhexidine rinse. Bottles have childproof caps, safety seals, and multi-panel wrap-around labels.
Paroex was distributed across the U.S. to dental offices, dental supply distributors, pharmaceutical wholesalers, dental schools, and pharmacies.
The manufacturer is notifying distributors and customers by USPS Priority Mail and is arranging for the return of all recalled products. Patients, pharmacies, and healthcare facilities with recalled rinses should stop using or distributing them.
Questions about this recall may be addressed to [email protected] or asked by phone at 1-800-528-8537 Monday through Friday, 9 a.m. to 6 p.m.
