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SAFETY BULLETINS

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.

April 16, 2018
 

In light of continuing complaints of quality issues involving certain prescription birth control pills, Health Canada is reminding women to check their packages of birth control pills. 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. Products affected: Birth control packages that contain damaged pills, an empty slot where a pill should be, or multiple pills in a slot where there should be only a single pill.

April 24, 2018
 

Health Canada is advising Canadians that one lot of “Throat Coat Lemon Echinacea” herbal tea is being voluntarily recalled by Traditional Medicinals after a company supplier found Salmonella contamination in a tea ingredient (lemon myrtle leaf). An infection caused by Salmonella bacteria may pose serious health risks, particularly for young children, pregnant women, the elderly and people with weak immune systems. The recalled product was sold at stores across Canada and online, including Amazon Canada, Bulk Barn, Loblaws, London Drugs and Walmart. It is promoted to relieve the symptoms and shorten the duration of upper respiratory tract infections. Products affected: Traditional Medicinals Throat Coat Lemon Echinacea herbal tea (NPN 80028539) Lot #019, Expiry date February 2021

April 30, 2018
 

These foreign health products have been found by regulators in other countries to contain undeclared drug ingredients. 7 Days Slim hip & Legs caps, CA NI CAP Arm Slim, Perfect Slim by Peenuch capsules, Slim Perfect Legs, Ure Tonic Herbal Traditional. The products are not authorized for sale in Canada and have not been found in the Canadian marketplace, but it is possible they may have been brought into the country by travellers or purchased over the Internet.

March 8, 2018

Further to a recent advisory about the recall of one lot of Alysena 28 birth control pills because of chipped pills, Health Canada is informing Canadians that all lots of both Alysena 21 and Alysena 28 may have chipped pills. Health Canada is reminding women to always check their pills carefully before taking them.

Alysena 21 and Alysena 28 are prescription drugs used to prevent pregnancy as well as to treat acne (in women 14 or more years of age). Alysena 21 contains 21 “active” pink pills, while Alysena 28 contains 21 “active” pink pills and 7 “inactive” white pills.

March 14, 2018

Severe cases of myocarditis have been reported in patients being treated with TECENTRIQ (atezolizumab) in clinical trials.  

Healthcare professionals are advised to: monitor patients receiving TECENTRIQ for signs and symptoms of myocarditis. Withhold TECENTRIQ therapy in patients with Grade 2 myocarditis. Permanently discontinue TECENTRIQ treatment in patients with Grade 3 or 4 myocarditis. Administer corticosteroids and/or additional immunosuppressive agents as clinically indicated to TECENTRIQ treated patients who develop myocarditis. The Canadian Product Monograph has been updated to include this new safety information.

March 16, 2018
 

Health Canada is advising Canadians that two versions of the sexual enhancement product “Leopard Miracle of Honey” may pose serious health risks. Both versions are labelled as being approved by Health Canada, with NPN 80073650. Health Canada’s testing found that both versions of the product contain the undeclared prescription drug sildenafil. The product was not authorized to contain this prescription drug. Health Canada seized the products from two Ontario convenience stores located in Woodbridge, ON, and suspended the product licence.