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Sunstar Americas Inc. Issues Voluntary Nationwide Recall of Paroex® Chlorhexidine Gluconate Oral Rinse USP, 0.12%, due to Microbial Contamination

·3 min read

GUELPH, ON, Dec. 24, 2020 /PRNewswire/ -- Sunstar Americas, Inc. (SAI) is voluntarily recalling Paroex® Chlorhexidine Gluconate Oral Rinse USP, 0.12% products bearing an expiration date from 12/2020 – 09/2022 to the consumer level. This product may be contaminated with the bacteria Burkholderia lata. This is an expansion of the recall initially announced on October 29, 2020.

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 Canada 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 (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.

1788C GUM® Paroex® "NEW ADDITION"
- is distributed in cases each containing 24 amber bottles of 4 fluid ounce (118 ml) chlorhexidine rinse. The bottle has a childproof cap, is safety sealed, and is decorated with a multiple-panel wrap-around label.

The products can be identified by as shown in the images below:

Paroex was distributed Nationwide to Dental offices, Dental distributors, Pharmaceutical wholesalers, Dental schools, and Pharmacies.

SAI is notifying its direct distributors and customers by email/fax/phone and 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 can.customerrelations@ca.sunstar.com. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to using this drug product.

AFFECTED PRODUCT

Product name: Paroex® Chlorhexidine Gluconate Oral Rinse USP, 0.12%

Size/ Form: 473 mL Amber Bottles
DIN #: 02384272

UPC#: 0 70942 304078

Product Code: 1789C

Lots Recalled: ALL Lots with expiration date from 2020/12 through 2022/09

Product name: Paroex® Chlorhexidine Gluconate Oral Rinse USP, 0.12%

Size/ Form: 118 mL Amber Bottles
DIN #: 02384272

Product Code: 1788C

Lots Recalled: ALL Lots with expiration date from 2020/12 through 2022/09

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.

For more information:
Contact us:
Phone: 1-800-265-8353
Email: can.customerrelations@ca.sunstar.com
Visit us at:
https://www.gumbrand.com/news-announcements.

SOURCE Sunstar Americas, Inc.