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


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GUELPH, ON, Dec. 24, 2020 /CNW/  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. ....

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