Medicine recalls
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| Canada: Five lots of anti-gingivitis oral rinse GUM Paroex recalled due to microbial contamination |
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Health Canada announces that Sunstar Americas, Inc. is recalling five lots of its prescription anti-gingivitis oral rinse, GUM Paroex (chlorhexidine gluconate 0.12%) (lot number: C177GS, C177GT, C177GU, C219DH and C219DJ), after testing by the company revealed the presence of Burkholderia lata.
Burkholderia lata is a multi-drug-resistant bacteria that has a high potential to cause serious respiratory and other infections in patients with underlying illnesses, such as cystic fibrosis and chronic granulomatous disease, or who are immunocompromised (such as some elderly individuals, people who are HIV positive and cancer patients undergoing chemotherapy or hemodialysis). Hospitalized patients who have catheters, are mechanically ventilated or are in the intensive care unit are at risk of severe, life-threatening infections if exposed to this bacteria through contaminated product. Those with a healthy immune system who use the contaminated product may risk infections requiring treatment with antibiotics.
GUM Paroex is a licensed, prescription anti-gingivitis oral rinse used for the treatment of moderate to severe gingivitis, and for the management of associated gingival bleeding and inflammation between dental visits.
Please refer to the following website in Health Canada for details:
http://healthycanadians.gc.ca/recall-alert-rappel-avis/hc-sc/../74233a-eng.php
In Hong Kong, the above product is not a registered pharmaceutical product. Related news was previously issued by the United States Food and Drug Administration, and was posted on the Drug Office website on 29 Oct 2020.
Ends/Friday, Oct 30, 2020
Issued at HKT 17:00
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