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SAFETY BULLETINS

January 25, 2018

On January 25, 2018, Aphria initiated a voluntary Type III recall for two lots of dried marijuana sold in 10 g bottles, due to a labelling error. The labels omitted to indicate the percent sign (%) next to the numerical values for cannabinoid content.

A Type III recall refers to a situation in which the use of, or exposure to, a product is not likely to cause any adverse health consequences.

To date, Health Canada has not received any adverse reaction reports for products sold by Aphria. However, Health Canada recommends that any individual affected by the recall immediately stop using the recalled product and contact Aphria at the following number 1-844-427-4742.

January 17, 2018

These foreign health products have been found by regulators in other countries to contain undeclared drug ingredients.

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. Adipessum Miracle Slimming Capsules, Beautiful Lose Weight, Blue Pearl All Natural Male Enhancement pill, Chong Cao Dan pills, Fruta Planta Life capsules, Hard Rod Plus capsules, Hard Times for Men capsule, Linsen Double Caulis Plus capsules, Lishou Fuling Jiaonang, Lose Weight 30, Red Ant, Super Soniic capsules, Wan Ling Ren Sem Chin Kuo Pill.

January 25, 2018

Health Canada is advising Canadians that it has seized several health products, including one kratom and 16 sexual enhancement products, from multiple George’s convenience stores located in the Greater Toronto Area (Brampton, Maple, Markham and Woodbridge). These products are not authorized by Health Canada and may pose serious health risks. Stop using these products. Consult your health care professional if you have used these products and have health concerns, and for advice on which health products are best for you and your family.

Read product labels to verify that health products have been authorized for sale by Health Canada. Authorized health products have an eight-digit Drug Identification Number (DIN), Natural Product Number (NPN) or Homeopathic Drug Number (DIN-HM). You can also check if products have been authorized for sale by searching Health Canada’s Drug Product Database and Licensed Natural Health Product Database.

December 22, 2017

Health Canada is advising Canadians and healthcare professionals that new safety warnings will be added to the product safety information of the following sedative and anesthetic drugs when they are used in early childhood and during pregnancy: Diprivan (propofol), Ketalar (ketamine), Sevorane (sevoflurane), Suprane (desflurane), Forane/Isoflurane USP (isoflurane), Ativan (lorazepam), midazolam, phenobarbital and thiopental. The Department conducted two reviews to assess the potential risk of adverse effects on the development of children’s brains when certain sedative and anesthetic drugs are used in pregnancy or in early childhood.

December 22, 2017 Unauthorized product alert: Ultra Pure Colloidal Silver health risks Health Canada is advising Canadians, especially children and pregnant women, not to use the unauthorized product Ultra Pure Colloidal Silver by ECG Naturals because it may pose a serious risk to health. Consumers taking this product are at risk of developing a condition called generalized argyria, which is the permanent bluish-gray discolouration of the skin, eyes and nails. At this time, there is no scientific evidence that supports the use of colloidal silver for any specific disease or condition in humans. The product may have been sold at retail stores across Canada.
January 11, 2018 Drug Alert: Risk of drug-induced liver injury for nintedanib (OFEV) Cases of drug-induced liver injury (DILI), including one fatal outcome, have been reported in patients treated with OFEV (nintedanib). In most of these cases, the DILI was reversible when the dose was reduced or treatment was stopped. The majority of the cases occurred within the first three months of starting OFEV. Therefore, particular attention is recommended during this initial period. Healthcare professionals are advised to monitor patients’ liver transaminases and bilirubin levels: just before starting treatment; at regular intervals (e.g., monthly) during the first three months of treatment; and periodically thereafter (e.g., at each patient visit) or as clinically indicated. Healthcare professionals are reminded that: If the transaminase (AST or ALT) levels are greater than three times the upper limit of normal (ULN), OFEV dosage should be reduced or treatment interrupted. OFEV therapy should be permanently discontinued if any liver test elevations are associated with clinical signs or symptoms of liver injury (e.g., jaundice). Health Canada is working with the manufacturer to include this safety information in the Canadian Product Monograph.
November 16, 2017 Recall: Cannabis for Medical Purposes On November 16, 2017, Aurora Cannabis Enterprises Inc. initiated a voluntary Type II recall for one lot of Sundance borealis blend (sativa), sold in 5 g bottles, due to an error in packaging of the product. The delta-9-tetrahydrocannabinol (THC) content identified on the label was higher and the cannabidiol (CBD) content identified on the label was lower than the concentration present in the product. For lot 17-118-2042, the products packaged contained a THC value of 16.2% instead of 8.17% THC, and a CBD value of 0.05% instead of 5.91% CBD. A Type II recall refers to a situation in which the use of, or exposure to a product may cause temporary adverse health consequences, or where the probability of serious adverse health consequences is remote.
November 17, 2017 Unauthorized product alert: Multiple sexual enhancement products Health Canada is advising Canadians about unauthorized health products that may pose serious health risks. The table is updated when 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.
Nov 24, 2017 Advisory: Breast Implants: Risk of Lymphoma Healthcare professionals including family physicians, obstetricians and gynaecologists, oncologists, general pathologists and hematopathologists, hematologists, radiologists, general and plastic surgeons. Rare cases of breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) have been reported in Canada and internationally. Available data, from literature and international regulators, suggest that BIA-ALCL occurs more frequently following implantation of breast implants with textured surfaces compared to those with smooth surfaces. Healthcare professionals are encouraged to learn more about the signs, symptoms and testing steps to recognize and diagnose BIA-ALCL. Health Canada is working with manufacturers to update this safety information on the product labelling for breast implants.
October 13, 2017 Information update: Mannitol and pregnancy Health Canada is aware of recent concerns around the use of mannitol as a non-medicinal ingredient in medications for use by pregnant women. Health Canada would like to reassure Canadians that, based on its evaluation of the evidence available to date, consumption of small quantities of sugar substitutes, including mannitol, during pregnancy does not pose a health risk. Mannitol is a type of sugar commonly used as a non-medicinal ingredient in medications, such as tablets or capsules, to help in the manufacture of the product. Non-medicinal ingredients are evaluated for safety. They are used, for example, to help hold a tablet together or give it colour. Mannitol has a long history of safe consumption in many products commonly used and consumed by pregnant women, including folic acid supplements, vitamins, candy and baked goods. Mannitol also occurs naturally in many foods, including cauliflower, mushrooms, snow peas, and peaches.
October 27, 2017 Foreign Product Alerts: Weight loss products These foreign health products have been found by regulators in other countries to contain undeclared drug ingredients. Body Con Plus capsules, Physic Candy, Define, 7-day slim extreme capsules. 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.
Nov 1, 2017 Advisory: Unauthorized sexual enhancement products seized Health Canada is advising Canadians that multiple unauthorized sexual enhancement products seized from four Toronto retail locations may pose serious risks to health. Stop using these products. Consult with your health care professional if you have used any of these products and have health concerns. Read product labels to verify that health products have been authorized for sale by Health Canada. Authorized health products have an eight-digit Drug Identification Number (DIN), Natural Product Number (NPN) or Homeopathic Drug Number (DIN-HM). You can also check whether products have been authorized for sale by searching Health Canada’s Drug Product Database and Licensed Natural Health Product Database.

September 11, 2017

Health Canada is advising of a recall of Setraline 50mg, as it may contain capsules of Sertraline 25mg.

September 15, 2017

Health Canada is advising of a recall of pms-Bisacodyl due to results not meeting specifications for the stability of the active ingredient content.

Sep 28, 2017

Health Canada is reminding Canadians and women in particular, that thermograms (which use thermal imaging) are not a substitute for mammograms used for routine monitoring and screening for breast cancer. While thermography devices are available in Canada, these devices have not been licensed in Canada to screen for breast cancer. They have been licensed by Health Canada only to measure skin temperature, similar to a thermometer.

Health Canada is not aware of any clinical evidence that thermography devices can be used effectively for the early detection of breast cancer. If women are relying solely on thermography results, there is a potential risk that cancer could go undetected.

Mammography, which is a low-dose x-ray system to see inside the breasts, is the most reliable technique in screening for early-stage breast cancer, and has been proven to be safe and effective. Specialized equipment used in mammography is licensed by Health Canada and is widely available across Canada.