Chlorhexidine Gluconate Oral Rinse Recall Expanded

December 31, 2020 – Sunstar Americas has expanded its October 2020 recall of Paroex® Chlorhexidine Gluconate Oral Rinse USP, 0.12%, to include all products with an expiration date from 12/31/2020 to 9/30/2022 to the consumer level. Affected products may be contaminated with Burkholderia lata, a type of bacteria that may pose a risk of infection.

For patients whose immune systems function normally, there is a chance that using the contaminated product could cause oral or systemic bacterial infections requiring treatment with antibiotics. In immunocompromised patients, infections may be life-threatening and lead to pneumonia or bacteremia (a bacterial infection of the bloodstream). As of the date of the recall expansion, 29 adverse events have been reported to the drug manufacturer. Affected patients tested positive for Burkholderia lata, which was typically identified in sputum cultures, while under treatment for other serious medical conditions. Sunstar Americas advises that use of the contaminated product in patients with pre-existing respiratory conditions, including COVID-19, is especially unsafe.

Paroex is available only through healthcare professionals for use as part of a professional program to treat gingivitis. Sunstar is notifying its direct distributors and customers by USPS Priority Mail and arranging for return of all recalled products. Patients, pharmacies, and healthcare facilities in possession of the recalled products should immediately stop use and dispensing. Consumer questions regarding the recall should be directed to Sunstar at 1-800-528-8537 or us.pcr@us.sunstar.com. Patients should contact their healthcare provider if they have experienced any problems that may be related to using the recalled product. Adverse events can also be reported to the FDA’s MedWatch program.

The full recall notice is available on the FDA’s website.

Due to the expanded Paroex recall, Precision Dose Inc. is recalling all lots of its Chlorhexidine Gluconate Oral Rinse USP, 0.12%, 15mL Unit Dose Cups bearing expiration dates from 1/31/2021 – 2/28/2022. The affected product was manufactured by Sunstar Americas.

There is no member impact through Benecard Central Fill for either recall.