Advisories and Recalls
OTTAWA - The Government of Canada is committed to better informing Canadians about the risks of health products that contain opioids. Following a safety review of cough and cold products containing opioids, Health Canada is advising that Canadian children and adolescents (under 18 years of age) should not use cough and cold products containing codeine, hydrocodone and normethadone, as a precautionary measure.
Health Canada is advising consumers that the unauthorized product "Kobayashi Aibon/Eyebon Eyewash" is labelled to contain a prescription drug (aminocaproic acid) and may pose serious health risks. The product is promoted as an eyewash for contact lens users and for the prevention of eye disease.
OTTAWA - Health Canada will be updating its safety review of breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) following an increase in reports of Canadian cases. As of January 1, 2019, Health Canada has received reports of 22 confirmed and 22 suspected Canadian cases of BIA-ALCL. In its initial safety review in 2017, Health Canada found that the rate of BIA-ALCL cases was low, with 5 confirmed Canadian cases of BIA-ALCL reported by Canadian manufacturers in the last 10 years. Increased awareness by healthcare professionals and the public about BIA-ALCL is believed to be the largest contributing factor to the increased reporting of cases of BIA-ALCL to Health Canada.
OTTAWA – Health Canada has completed a safety review of hydrochlorothiazide and has found that prolonged use of the drug could increase a person’s risk for non-melanoma skin cancer.
Health Canada is warning Canadians that Ayurvedic products sold by A1 Herbal Ayurvedic Clinic Ltd. may pose serious health risks.
Health Canada is advising Canadians that Panasilver, a product distributed by Activation Products Canada Inc., in Cobourg, Ontario, is not authorized for sale and may pose serious health risks.
OTTAWA – Health Canada is informing Canadians that its safety review of Fibristal (ulipristal acetate) found a possible link between its use and the risk of a rare but serious liver injury.
Teva Canada is voluntarily recalling one lot (Lot 150261) of two products because of a labelling error. While the outer carton of Equate brand Lens Care System is correctly labelled, the bottle within the carton is mislabelled as Equate brand Multi-Purpose Solution. Because of the labelling error, the company is recalling both products labelled with Lot 150261. Bottles labelled as Equate Multi-Purpose Solution should contain a 0.0001% w/v polyhexanide based disinfecting solution for rinsing. The mislabelled bottles contain the Equate Lens Care System, which is a 3.3% hydrogen peroxide cleaning and disinfecting solution and should not be used for rinsing. The labelling error could cause consumers to use the product in a way that is not intended, such as rinsing contact lenses before insertion. This could lead to temporary adverse health effects, such as eye stinging, burning or irritation, which could require medical treatment.
Health Canada is warning Canadians that Pace, a shot-sized drink that is being promoted as an alcohol substitute, contains an active ingredient—5-methoxy-2-aminoindane (MEAI)—that is similar in structure to amphetamines and may pose serious health risks. Pace is being sold online by the Diet Alcohol Corporation of the Americas.
Health Canada has released the results of its testing of sartan drugs in Canada. Health Canada tested samples of certain sartan drugs (valsartan, candesartan, irbesartan, losartan, and olmesartan), which represent numerous products, as part of its ongoing collaborative work to address impurities found in some sartan drugs in Canada and internationally.
December 17, 2018 For immediate release
Health Canada is warning that all products manufactured by Professional Botanicals Inc. may pose serious health risks. The company is a contract manufacturer that also operates under the name Healthy Botanicals Inc.
OTTAWA – The holidays are a great time to get together with family and friends. However, holiday traditions can involve some safety risks that may not be found at other times of the year. Health Canada reminds Canadians to follow these tips for a safe and happy holiday season.
Health Canada is advising Canadians about unauthorized health products that may pose serious health risks. Thetable belowis 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. Links to previous tables with affected products are also available below.
Laboratoire RivaInc. and Laboratoires Trianon Inc. are voluntarily recalling five over-the-counter strawberry-flavoured acetaminophen oral drops for infants. The products are labeled as Biomedic, Option, Personnelle, Selection, or Laboratoires Trianon Inc. The products are packaged in 24 mL bottles and are used for pain and fever relief. They are being recalled because the child-resistant safety cap may be defective. This recall is in addition to previous recalls of children’s acetaminophen syrups for the same issue.
November 30, 2018 For immediate release
Mylan Pharmaceuticals ULC is voluntarily recalling four lots of Mylan-Valsartan tablets (40 mg, 80 mg, 160 mg and 320 mg strength) after testing found low levels of an impurity, N-nitrosodiethylamine (NDEA).
November 27, 2018 For immediate release