July 6, 2020

Health Canada Recall: Hand Sanitizers

Health Canada is advising Canadians that certain hand sanitizers containing technical-grade ethanol are being recalled from the market because they are not compliant with federal regulations and may pose a risk to health.

Given supply shortages of pharmaceutical- and food-grade ethanol, on April 15, 2020, Health Canada permitted the temporary use of technical-grade ethanol in alcohol-based hand sanitizers.

Manufacturers wishing to use technical-grade ethanol must choose from a list of Health Canada-authorized suppliers and receive a No Objection Letter from Health Canada before manufacturing or distributing the product. Technical-grade ethanol contains more impurities than pharmaceutical- and food-grade ethanol.

Health Canada is advising Canadians to stop using the products on the list below. The Department will update this list if it becomes aware of other affected products, so that Canadians can easily identify ones they may have purchased and take appropriate action. Canadians are encouraged to consult the list regularly for updates.

July 2, 2020

Health Canada Drug Advisory: Picato may increase skin cancer

Health Canada has found that there may be a link between the drug Picato and an increased risk of skin cancer. Health Canada undertook a safety review to examine this potential link after learning of new safety information from international clinical trials. The Department's review included information from clinical trials, Canadian and international case reports, scientific and medical literature and what is known about the use of this drug both in Canada and internationally.

Picato (ingenol mebutate) is a topical prescription drug used to treat adults with actinic keratosis, which causes thick, hard and scaly patches on skin damaged as a result of too much sun exposure. It is available in two strengths: 0.015% and 0.05%.

Since a potential link between the use of the medication and an increased risk of cancer has been established, Health Canada is now seeking additional information from the manufacturer to determine whether the benefits of Picato as a treatment option for actinic keratosis continue to outweigh its risks.

The Department will continue to monitor safety information involving Picato to identify and assess potential risks, as it does for all health products on the Canadian market and will take appropriate and timely action if new health risks are identified.

July 6, 2020
Health Canada Alert: Counterfeit respirators

Health Canada has identified counterfeit respirators in Canada and is advising consumers to stop using them as they may not protect Canadians against the virus that causes COVID-19. Counterfeit respirators are imitations of legitimate products. There are no assurances that they provide protection or prevent harm.

Health Canada is taking action to stop the import and sale of counterfeit respirators in Canada. The Department directs companies that may be importing or distributing these respirators to remove them from the market since they are not permitted to be sold in Canada. Health Canada will also cancel authorizations when there are reasonable grounds to believe that a product is counterfeit.

Health Canada will continue to take action and update the list of counterfeit respirators below as needed.

May 7, 2020

Health Canada Alert: Unauthorized test kits diagnosing COVID-19

Health Canada is warning Canadians not to buy home diagnostic test kits, including mail-in sample collection kits, claiming to diagnose or detect COVID-19 because they may provide inaccurate or false results. These products have not been authorized by Health Canada, which means they have not been reviewed for safety, quality or effectiveness.

Health Canada has authorized COVID-19 test kits intended for use only by healthcare professionals or trained operators.

The Department continues to monitor websites for false claims and is working with online retailers to ensure that unauthorized COVID-19 diagnostic or detection test kits are removed from their websites.

Health Canada is also working with the RCMP to take action when unauthorized test kits are found to be sold in Canada, including a recent seizure of over 1500 test kits in B.C.

Selling or advertising health products that make false or misleading claims is illegal in Canada. The Department takes this issue seriously and will use all mechanisms and tools at its disposal to stop these activities.

May 11, 2020

Health Canada Alert: Important safety information for respirator masks

Health Canada is committed to ensuring that the medical devices available to Canadians meet the necessary safety and effectiveness standards. The Department has contacted companies that may be importing or distributing certain respirators, including KN95 respirators, that may not meet expected performance standards in Canada to request that they stop sale and relabel the products as face masks instead of respirators.

This follows the recent U.S. Food and Drug Administration (FDA) communication regarding concerns that certain filtering facepiece respirators from China may not provide consistent and adequate respiratory protection based on testing conducted by the National Institute for Occupational Safety and Health (NIOSH) - National Personal Protective Technology Laboratory (NPPTL) of the Centers for Disease Control and Prevention (CDC).

Health Canada has asked importers and distributors that may have imported respirators that do not meet performance standards to notify their customers and relabel products to indicate that while these masks may not meet the standards required for frontline healthcare workers, they could be used as face masks in settings where a 95% filtration is not needed. The products are not being removed from the market.

April 17, 2020

Salbutamol relieves the acute symptoms of medical conditions such as asthma, chronic obstructive pulmonary disease (COPD) and other respiratory conditions, such as coughing, wheezing and feeling breathless. It relaxes the muscles of the airways, making it easier to breathe.

Some manufacturers have reported shortages of this product on www.drugshortagescanada.ca because of an increase in demand related to the current COVID-19 pandemic. At this time, to manage and conserve supply, most patients will receive only one inhaler at a time when they go to refill their prescription.

Health Canada understands the stress caused by the COVID-19 pandemic and recognizes that Canadians may be concerned about not being able to get the medications they rely on for themselves and their loved ones.

The health and safety of Canadians is Health Canada’s first priority. We are working closely with other federal departments, provincial and territorial governments, international partners, and industry to help minimize the impact of this shortage and to help ensure that Canadians have access to the drugs they need during the COVID-19 pandemic. This includes exploring access to international supplies and working with companies that are able to ramp up production, to increase supplies in Canada.

April 15, 2020

Proper hygiene and disinfection is essential during the COVID-19 outbreak to reduce the risk of infection. Washing your hands frequently with soap and water for at least 20 seconds remains the most effective way to limit the spread of COVID-19. If soap and water are not available, a hand sanitizer, with at least 60% alcohol, that has been approved by Health Canada should be used.

There are a variety of hand sanitizers that meet Health Canada's requirements for safety, efficacy and quality and have been approved. They are listed on Health Canada's website.

March 30, 2020

Health Canada understands the stress caused by the COVID-19 pandemic and recognizes that Canadians may be concerned about not being able to get medications they rely on for themselves and their loved ones.

While the Government of Canada recommends that Canadians refill their prescriptions now so that they do not have to go to a pharmacy if they become sick, we are urging patients not to buy more medication than usual. This will help ensure that all Canadians continue to have access to the medications they need and it will also help prevent drug shortages.

Patients are encouraged to contact their health care provider to renew their prescriptions ahead of time. Health Canada is also calling on health professionals to avoid prescribing or dispensing larger supplies of medication than necessary, unless there is a specific medical reason to do so. Increased demand and stockpiling of medications can lead to local shortages, which means that some may not be able to get the treatments they need.

February 14, 2020

Health Canada is recalling Ultra 03 due to incorrect label (Ultra-03) appended to affected lot that contains: Adiposlim. The NPN is 80081311. It contains Coenzyme Q10, fish oil, and phytosterols. For more information on this recall, please contact Health Canada directly.

February 19, 2020

Product: Various unauthorized health products promoted for sexual enhancement, weight loss, as a workout aid, or as “poppers”. Issue: Products may contain dangerous ingredients such as prescription drugs that are not listed on the label, or the label may indicate a dangerous ingredient or combination of ingredients.  What to do: Stop using these products and consult your healthcare professional if you have health concerns. Report these or any unauthorized health products to Health Canada.

February 26, 2020

Health Canada is recalling Pro Doc Zolmitriptan ODT because it is out of specification result for impurity stability. The DIN is 02379988. For further information on this recall, please contact Health Canada directly.

November 26, 2019

Unauthorized Advisory: Ayurvedic products in BC may pose health risks

Health Canada is warning Canadians that Ayurvedic products sold by Dutta Health Centre-Ayurvedic Clinic in Surrey, British Columbia (Unit 109 - 12888 80th Avenue), may pose health risks. Health Canada testing of some of the Ayurvedic products from the clinic found that they contained high levels of lead and mercury. Lead and mercury may pose serious health risks when consumed in excessive amounts. Children, pregnant women and breastfeeding women are most susceptible to their toxic effects.

The testing was prompted by a report from the Fraser Health Authority in British Columbia of a case of lead poisoning of a patient who had been using Ayurvedic products from the clinic. Ayurvedic medicinal products are used in traditional Indian healing practice and are often imported from India. Improper manufacturing processes may result in dangerously high levels of heavy metals in the final product, which, when consumed, may accumulate in vital organs and cause serious health effects.

December 2, 2019
Health Canada Alert: Xeljanz (tofacitinib) risk of thrombosis

An increased incidence rate of thrombosis, including pulmonary embolism, deep vein thrombosis, and arterial thrombosis was observed in patients treated with XELJANZ (tofacitinib) in a large, ongoing post-marketing study. The study showed that patients with rheumatoid arthritis and at least one cardiovascular risk factor should not have their dose doubled given the risk of thrombosis.

December 5, 2019
Drug Warning: Health Canada evaluating NDMA in metformin drugs

Health Canada is aware that some metformin products available outside Canada have been found to contain a nitrosamine impurity, N-nitrosodimethylamine (NDMA), above the acceptable limit. Metformin is a prescription drug used to control high blood sugar in patients with type 2 diabetes.

At this time, Health Canada is not aware of any metformin products in Canada containing NDMA above acceptable levels. The Department has asked companies to test their metformin products and is collecting samples from companies to conduct its own testing. Health Canada is also working closely with international regulatory partners to inform its assessment of the issue and to determine whether any metformin product in Canada is affected. If a risk to Canadians is identified, the Department will take action as needed and inform Canadians. 

October 24, 2019

Multiple drug manufacturers continue to recall Ranitidine from the market. Please contact Health Canada or your healthcare provider if you are using this drug.