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Bacterial Contamination Prompts Recall of Certain Lots of GUM Paroex Mouthwash


— October 29, 2020

Sunstar Americas recently issued a recall for certain lots of GUM Paroex mouthwash that might be contaminated with a dangerous bacteria.


Alert graphic
Alert graphic; image courtesy of Clker-Free-Vector-Images via Pixabay, www.pixabay.com

Sunstar Americas recently announced a recall for 37 lots of GUM Paroex Chlorhexidine Gluconate Oral Rinse over concerns it may be contaminated with Burkholderia lata. According to the FDA, the bacteria may cause “oral and, potentially, systemic infections requiring antibacterial therapy.” When at-risk populations are exposed to the bacteria, it may even result in life-threatening infections, including bacteremia and pneumonia.

The prescription mouthwash is designed to treat gingivitis. A list of the affected products includes the following:

GUM Paroex 16-ounce bottles recalled chart.JPG

If you use the mouthwash and experience a medical problem, contact your healthcare provider and report the issue to the FDA’s MedWatch Adverse Event Reporting program on the FDA website or by a form obtained at 800-332-1088. If you have additional questions or concerns regarding the recall, contact Sunstar Americas at us.pcr@us.sunstar.com or call 800-528-8537.

Sources:

37 lots of a mouthwash have been recalled for a possible bacterial contamination

Advisory – Five lots of anti-gingivitis oral rinse GUM Paroex recalled due to microbial contamination

 

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