WINNIPEG — Sunstar Americas Inc. announced on Monday that it has voluntarily recalled one of its mouth rinses due to the possibility of bacteria contamination.
According to a news release, the affected products are Paroex Chlorhexidine Gluconate Oral Rinse USP, 0.12 per cent with expiration dates from Dec. 31, 2020 to Sept. 30, 2020. This prescription mouth rinse is only available through health-care professionals and is part of a program to treat gingivitis.
Sunstar notes this product could be contaminated with a bacteria called ‘Burkholderia lata,’ which could cause oral and systemic infections that require antibacterial therapy. Sunstar adds that for at-risk people, the use of this product could cause life-threatening infections, including pneumonia.
The product is also particularly unsafe for those with pre-existing respiratory conditions, including COVID-19.
The recalled items are packaged as:
- 1789P GUM Paroex and distributed in cases with six amber bottles of 16 fluid ounce chlorhexidine rinse. The bottle has a childproof cap and a 15 millilitre metered dosage cup; and
- 1788P GUM Paroex and distributed in cases with 24 amber bottles of four fluid ounce chlorhexidine rinse. The bottle has a childproof cap.
To date, Sunstar has received reports of 29 adverse events related to this product, with people testing positive for Burkholderia lata infections.
Sunstar is notifying its distributors and customers of this recall by mail and is arranging the return of the recalled products. Patients, pharmacies and health-care facilities with this product should stop using it immediately.
The company says that anyone who is experiencing issues that could be related to this product should contact a doctor or health-care provider.
This recall is an expansion of an earlier recall from Oct. 27, 2020.
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