Health Canada has recently announced the recall of three health products over potential risks that, in some cases, could be life-threatening.
GUM Paroex Recalled Over Multi-Drug-Resistant Bacteria Contamination
On Dec. 24, Health Canada announced a recall of the anti-gingivitis oral rinse GUM Paroex due to bacterial contamination. According to the Health Canada announcement, some lots of GUM Paroex are contaminated with Burkholderia lata, which is associated with serious respiratory ailments and other infections that may be life-threatening.
Burkholderia lata is reportedly a type of bacteria that is resistant to multiple drugs. The bacteria may cause serious respiratory infections and other types of infections in patients with certain underlying conditions or who are immunocompromised.
The drug identification number for GUM Paroex is 02384272.
This latest GUM Paroex recall adds to the lots that were subject to a recall in October. The recalled products include GUM Paroex (Chlorhexidine Gluconate Oral Rinse USP, 0.12%).
Sunstar Americas Inc. agreed to a voluntary recall of five lots of GUM Paroex on Oct. 29. This latest GUM Paroex recall affects products with an expiration date ranging from December 2020 through September 2022. A full list of the recalled lots and their expiration dates is available here.
Check the labels of any GUM Paroex products before you use them to confirm that they are not included in the recall. If you have used the product and are experiencing any respiratory symptoms, contact your healthcare provider immediately.
ELMIRON Recalled After Pigmentary Maculopathy Reports
On Dec. 15, Health Canada announced a recall of ELMIRON (pentosan polysulfate sodium) over the risk of pigmentary maculopathy. ELMIRON is used to treat interstitial cystitis, a condition involving the inflammation and irritation of the bladder wall.
Several cases of pigmentary maculopathy have been reported in patients who have taken ELMIRON for long-term use, and the changes may be irreversible. According to the ELMIRON recall announcement, ELMIRON is now contraindicated in patients who have a history of any macular pathology.
The recall affects 100 mg capsules of ELMIRON.
Health Canada advises healthcare professionals to assess the benefits and risks with their patients before administering ELMIRON and to conduct periodic retinal examinations of patients who take the medication.
Patients who take ELMIRON should also report any changes in their vision to a healthcare professional.
ELMIRON Vision Damage Class Action Lawsuits
Jannsen Inc., the maker of ELMIRON, has already been hit with several ELMIRON class action lawsuits over the permanent vision changes potentially linked to long-term use of the drug.
The plaintiffs in these ELMIRON class action lawsuits allege they have suffered symptoms of pigmentary maculopathy after taking the medication for several years. They claim that Janssen knew or should have known of the risks of ELMIRON pigmentary maculopathy but failed to warn healthcare professionals and patients about the risk.
According to one ELMIRON class action lawsuit, tens of thousands of patients may have been harmed due to the alleged misrepresentation of the drug as safe and effective.
Maskopia Personal Protective Equipment Recalled Over False Advertisements
On Dec. 22, Health Canada announced that various PPE sold by Maskopia does not provide the level of protection advertised. Maskopia was formerly known as Medkem Canada Inc.
Health Canada says that Maskopia was selling PPE via websites and social media without first acquiring the required Medical Device Establishment License (MDEL) from Health Canada. A MDEL is required to import or sell medical devices in Canada.
According to the Maskopia PPE recall announcement, Maskopia continued to sell unapproved isolation gowns despite Health Canada’s orders to stop selling them. Maskopia also has allegedly falsely advertised non-medical masks as medical masks.
Health Canada has reportedly seized the following Maskopia PPE products:
If you purchased any PPE from Maskopia, you should immediately stop using the products and dispose of them, according to Health Canada.
This content was originally published here.