OTTAWA – Sunstar Americas Inc. is expanding its recall for its prescription anti-gingivitis oral rinse, GUM Paroex, to all lots on the Canadian market. The additional lots are being recalled, as a precaution, because they may be contaminated with the bacteria 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).
In addition to the lots that were recalled in October 2020, the affected new lots of GUM Paroex (DIN: 02384272 – 0.12% chlorhexidine gluconate) being recalled.
Health Canada is advising:
- Do not use rinses labelled with one of the lot numbers listed below.
- Consult your healthcare provider immediately if you’ve taken this product and are experiencing respiratory or other medical issues.
- Report any health product-related adverse reactions or complaints to Health Canada.
Health Canada will monitor the effectiveness of the recall and continue to inform Canadians if new safety information arises.
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 the 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 to treat moderate to severe gingivitis, and for to manage associated gingival bleeding and inflammation between dental visits. The product is distributed to patients in Canada through dental clinics and pharmacies.