Sunstar Americas, Inc. is recalling five lots of its prescription anti-gingivitis oral rinse, GUM Paroex, 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 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. Health Canada is monitoring the effectiveness of the company’s recall and the implementation of any necessary corrective and preventative actions.
RecallTracker