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SAFETY BULLETINS

September 28, 2018

Pfizer Canada has advised Health Canada that, in a very small number of cases, some EpiPen (0.3 mg) and EpiPen Jr (0.15 mg) auto-injector devices may not slide out of their carrier tube easily, or at all. This could delay or prevent emergency treatment, possibly leading to patient disability or death.

According to the company, the device label has been improperly applied to a very small number of devices in a way that the device label may become stuck to the inside of the carrier tube. This could mean that the device does not slide out of the tube as easily as expected. The issue is with the device label, and not with the device itself or the drug that it delivers (epinephrine).

EpiPen and EpiPen Jr are used to deliver an emergency treatment of adrenaline (epinephrine) to patients who are at risk or have a history of life-threatening allergic reactions (anaphylaxis).

Products are not being recalled by Pfizer, as the risk can be mitigated easily by pharmacists and patients by checking devices before an emergency situation arises to make sure they slide easily out of their carrier tube.

September 25, 2018

Hydroquinone is used to lighten dark spots on the skin such as age spots, liver spots or freckles. However, Health Canada recommends that products for use on the skin that contain high concentrations of hydroquinone be used with caution and only under the supervision of a health care professional.

There are a number of risks associated with skin-lightening products that contain hydroquinone at concentrations greater than 2%.

These products may:

  • cause severe skin redness, burning or stinging, dryness or cracking of the skin, blisters or oozing, or skin discolouration;
  • cause cancer in laboratory animals, and potentially in humans; and,
  • be harmful to the environment.

September 20, 2018

Canadians should not buy or use health products that contain 2,4-dinitrophenol, more commonly known as DNP, because it is toxic and can cause death. Products containing DNP are primarily marketed towards bodybuilders and are promoted online as a "fat burner" or "shredder" and for weight loss. There are currently no health products containing DNP approved by Health Canada because of serious safety concerns.

In the United Kingdom, five deaths between January 2018 and June 2018 have been linked to the use of DNP. Health Canada has been made aware that some Canadians may have purchased products containing DNP online. No deaths have been reported in Canada to date.

September 1, 2018

Health Canada is advising consumers and pet owners not to use homeopathic and veterinary products made by King Bio Inc. and labeled as "Dr. King's," "Dr King's Natural Pet" or "Natural Pet." These products may pose a health risk to people and pets, especially children, pregnant women and those with compromised immune systems, because of potential microbial contamination. According to the United States Food and Drug Administration, high levels of microbial contamination were identified at the manufacturing site in Asheville, North Carolina.

The products are being recalled by the Canadian distributor, Ecotrend Ecologics Ltd., and include products for children, adults and pets. They are promoted for various uses, including flu relief, respiratory care, arthritis and joint pain, and stress control.

August 27, 2018

Health Canada is advising Canadians that several unauthorized products seized from Vitality Health Foods in Drayton Valley, AB, may pose serious health risks. The 11 products include vitamins, dietary supplements, workout supplements and decongestants. Seized products were labelled to contain various ingredients, including prescription drugs and controlled substances.

August 17, 2018

Recalled Products

Teva-Valsartan/HCTZ 80mg/12.5mg Tablet

Teva-Valsartan/HCTZ 160mg/12.5mg Tablet

Teva-Valsartan/HCTZ 320mg/12.5mg Tablet

Teva-Valsartan/HCTZ 160mg/25mg Tablet

Reason

Affected lots may be manufactured with an API containing a contaminant.

June 28, 2018

Last summer, Health Canada received a higher than expected number of reports of skin reactions suspected of being associated with Banana Boat sunscreen products. As a result of these reports, Health Canada tested a wide range of sunscreen brands and has now released a summary of the results.

The Department tested 27 sunscreens from various companies in its laboratories: 18 intended for use on children or infants, and 9 intended for use on adults.

Health Canada’s testing did not identify any serious concerns with the quality of these products. Of the sunscreens tested:


  • All products were found to have a pH range close to the skin's natural pH level.
  • All products contained the amount of active ingredient that was listed on the product label.
  • None of the products contained the preservatives known to cause skin reactions: methylisothiazolinone and methylchloroisothiazolinone.
  • None of the products contained microbial contaminants above allowable levels.
July 9, 2018

Several drugs containing the ingredient valsartan are being recalled by their manufacturers. An impurity, N-nitrosodimethylamine (NDMA), was found in the valsartan used in these products. The valsartan was supplied by Zhejiang Huahai Pharmaceuticals. NDMA is a potential human carcinogen, which means that it could cause cancer with long-term exposure. Five companies have affected products, which are being recalled (identified in table below).

Drugs containing valsartan are used to treat patients with high blood pressure to help prevent heart attacks and stroke. These drugs are also used in patients who have had heart failure or a recent heart attack.

August 1, 2018

Health Canada seized eight unauthorized skin lotions and creams from Ayotai Canada because they are labelled to contain a prescription drug (clobetasol propionate or betamethasone dipropionate). The unauthorized lotions and creams were distributed by Ayotai and sold by various retailers in Quebec.

Prescription drugs can only be dispensed by a healthcare professional to a patient with a valid prescription. The products listed have not been evaluated by Health Canada for safety, effectiveness or quality and may pose serious health risks.

June 22, 2018

Arctic Sun 5000e Temperature Management System is being recalled. To inform customers of a voluntary field correction on all ARCTIC SUN 5000 Temperature Management Systems. An improper wiring connection on the chiller assembly may result in overheating of the connection and potential failure of certain components in the system. Bard will conduct repairs of this wiring connection either on-site or at an authorized service depot.

June 22, 2018

With the growing availability of fentanyl test strips on store shelves and online, Health Canada would like to remind Canadians of the potential limitations when using fentanyl test strips to detect fentanyl or other deadly substances in street drugs before consuming them.

No fentanyl test strips are specifically designed to check street drugs before consumption. Some strips are designed to detect fentanyl and some analogs (similar chemicals, such as carfentanil) in an individual's urine sample to determine whether they have taken the drug. Others are designed to detect fentanyl and some analogs in substances that are, for example, seized by law enforcement. Therefore, it is important that people who are using fentanyl test strips to check street drugs before consuming them understand the limitations and use the necessary precautions. Health Canada is reminding Canadians that to help prevent a fatal overdose, it is important to treat all street drugs as though they are potentially contaminated with unknown deadly substances.

June 14, 2018

Health Canada is advising Canadians about unauthorized health products that may pose serious health risks. Health Canada finds unauthorized health products that are promoted for sexual enhancement, weight loss, as a workout aid, or as “poppers,” and that are labelled to contain or have been tested and found to contain dangerous ingredients. Unauthorized health products have not been approved by Health Canada, which means that they have not been assessed for safety, effectiveness and quality. Unauthorized health products can pose many health dangers.

June 1, 2018 

Pfizer Canada Inc. has notified Health Canada that it has received complaints of broken or chipped pills involving Demulen 30, a prescription birth control pill. Health Canada has previously communicated on similar issues involving two other brands of birth control pills. Health Canada continues to remind women to check their packages of birth control pills and to report problems if they see them. If you notice anything unusual in the package, such as missing or damaged pills, you should return the package to the pharmacy for replacement as soon as possible. Skipping a dose because the pill is missing, or taking a damaged (for example, chipped or fragmented) pill, may increase the risk of pregnancy because less active ingredient may be taken. It is important to get a replacement package as soon as possible to avoid missing any doses.

June 1, 2018

Health Canada would like to remind Canadians to protect themselves and their families from the sun. Exposure to the sun’s harmful UV rays without sunscreen can cause much more than a sunburn. It can lead to sun damage (such as skin wrinkling and hardening, dark patches, precancerous skin changes) and can increase the risk of skin cancer.

There are many sunscreen products available in Canada. It is important to choose a sunscreen with the level of sun protection factor (SPF) that is right for you. The SPF tells you the level of protection that the sunscreen provides against sunburn. It also tells you the length of time that your sunscreen-protected skin can be exposed before it starts to get red.

Health Canada recommends using a broad-spectrum sunscreen with SPF 30 or higher. At this time, Health Canada does not have enough scientific information demonstrating that products with SPF higher than 50 provide additional protection.

June 5, 2018

Health Canada is advising Canadians about unauthorized health products that may pose serious health risks. Products promoted for sexual enhancement, weight loss, as a workout aid, or as “poppers,” and that are labelled to contain or have been tested and found to contain dangerous ingredients. Unauthorized health products have not been approved by Health Canada, which means that they have not been assessed for safety, effectiveness and quality. Unauthorized health products can pose many health dangers, including:

They may contain ingredients not listed on the label. This includes ingredients like prescription drugs, possibly at doses exceeding maximum recommended amounts. Prescription drugs should be taken only under the supervision of a health professional because they may cause serious side effects. Using a product that contains ingredients that the consumer is not aware of increases the chance of dangerous allergies and interactions with other medications and foods.

The label may indicate a dangerous ingredient or combination of ingredients. For example, it could list a drug that should be available only by prescription from a heath care professional, or a combination of ingredients that Health Canada does not permit because of serious health risks.