Sunstar Americas, Inc. Issues Voluntary Nationwide Recall of Paroex® Chlorhexidine Gluconate Oral Rinse USP, 0.12%, 473ml due to Microbial Contamination
Sunstar Americas, Inc. (SAI) is voluntarily recalling Paroex® Chlorhexidine Gluconate Oral Rinse USP, 0.12% products bearing an expiration date from 6/30/22 – 9/30/22 (see specific lots below) to the consumer level. This product may be contaminated with the bacteria Burkholderia lata.
Use of the defective product in the immunocompetent host may result in oral and, potentially, systemic infections requiring antibacterial therapy. In the most at-risk populations, the use of the defective product may result in life-threatening infections, such as pneumonia and bacteremia. To date, no adverse events have been reported to SAI related to this recall.
The prescription oral rinse product, available through healthcare professionals only, is indicated for use as part of a professional program for the treatment of gingivitis and the product impacted is:
1789C GUM® Paroex® UPC 0 70942 30407 8
- is distributed in cases each containing 6 amber bottles of 16 fluid ounce (473ml) chlorhexidine rinse. The bottle has a childproof cap and a 15ml metered dosage cup, is safety sealed, and is decorated with a multiple-panel wrap-around label.
Paroex was distributed Nationwide to Dental offices, Dental distributors, Pharmaceutical wholesalers, Dental schools, and Pharmacies.
SAI is notifying its direct distributors and customers by Canada Post Express and is arranging for return of all recalled products. Patients, pharmacies, and healthcare facilities in possession of these products should stop using and dispensing immediately.
Consumers with questions regarding this recall can contact SAI at 1-800-265-8353 (Monday – Friday, 8:30 AM to 5:00 PM EST) or by email to [email protected]. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to using this drug product.
Affected products and lot numbers follow below:
Affected Lot information – Paroex 473ml (DIN 02384272)/ SKU 1789C / UPC 0 70942 30407 8
Patients should contact their physician or healthcare provider if they have additional questions or concerns. Adverse reactions or quality problems experienced with the use of this product may be reported to the Health Canada’s MedEffect Adverse Reaction Reporting program online at https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/adverse-reaction-reporting.html.
Sunstar is committed to delivering safe, fully compliant products of the highest quality and is taking necessary steps to prevent future occurrence of this issue.
This recall is being conducted with the knowledge of Health Canada.
About Sunstar Americas Inc.
Sunstar Americas, Inc., a member of the Sunstar Group of companies, is a global organization headquartered in Switzerland that is a leader in the oral care industry and the manufacturer and distributor of the GUM and Butler Brands.