OTTAWA, Sept. 22, 2017 /CNW/ -
IssueHealth Canada is advising Canadians that it has seized 10 unauthorized health products that may pose serious risks to health. The products were seized from Isabella Beauty Salon, at 86 Finch Ave E., North York, ON.
The products seized include injectable and topical drugs that are packaged and labelled in Japanese, Korean or Chinese. As a result, information about ingredients, usage, dosage and side effects may not be understood by all users. None of the products are authorized for sale in Canada, which means they have not been assessed for safety, effectiveness or quality.
Who is affected
Background
Aminogen-X is a product containing amino acids, vitamins and minerals. The target population and indication for use is not clearly identified on the product label. Potential risks associated with injecting this unauthorized product may include infection at the site of injection and sepsis (blood poisoning). Patients with liver or kidney impairment may experience complications, including increased ammonia levels in the blood, fluid and electrolyte imbalance, impaired consciousness and even coma.
Liporase is a product labelled to contain hyaluronidase. Products containing hyaluronidase are used in ophthalmic surgery and are reportedly also used experimentally in some countries to manage complications from cosmetic procedures. The potential risks associated with injecting a hyaluronidase product can include redness of the skin, irregular heartbeat, confusion and blurred vision. Additionally, serious side effects can occur when certain medicines are used together with hyaluronidase.
Sodium Chloride 0.9% is a fluid and electrolyte replacement product. Potential risks associated with injecting this unauthorized product may include infection at the site of injection or sepsis. Patients with heart failure, kidney failure or liver failure who receive this product may be at increased risk for fluid and electrolyte imbalances.
J-CAIN is labelled to contain lidocaine. Lidocaine cream is considered safe when used in small amounts and low concentrations over small areas of the body. However, this cream is labelled to contain a 15.6% concentration. Health Canada has not done a safety review of creams containing lidocaine at a high concentration. When 15.6% lidocaine cream is applied on the body, a significant amount of lidocaine may be absorbed into the bloodstream, which may cause the buildup of toxic levels of lidocaine in the body. The toxicity of lidocaine can be local or systemic. Symptoms of local toxicity may include redness, itching, burning and swelling in the application area. Systemic toxicity most often affects the central nervous system or the cardiovascular system. Severe symptoms of systemic toxicity may include irregular heartbeat, difficulty breathing, seizure, coma and death.
For more information
Stay connected with Health Canada and receive the latest advisories and product recalls using social media tools.
To learn more about natural health products and other self-care products, visit Canada.ca/selfcare-products.
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IssueHealth Canada is advising Canadians that it has seized 10 unauthorized health products that may pose serious risks to health. The products were seized from Isabella Beauty Salon, at 86 Finch Ave E., North York, ON.
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The products seized include injectable and topical drugs that are packaged and labelled in Japanese, Korean or Chinese. As a result, information about ingredients, usage, dosage and side effects may not be understood by all users. None of the products are authorized for sale in Canada, which means they have not been assessed for safety, effectiveness or quality.
Who is affected
- Consumers who have been administered or used any of these products.
- See chart in the PDF.
- Do not use these products from Isabella Beauty Salon or from other locations. Consult with your health care professional if you have used or been administered 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.
- Report adverse events to health products to Health Canada by calling toll-free at 1?866?234?2345, or by reporting online, by mail or by fax.
- Report complaints about health products to Health Canada by calling toll-free at 1?800?267?9675, or complete an online complaint form.
Background
Aminogen-X is a product containing amino acids, vitamins and minerals. The target population and indication for use is not clearly identified on the product label. Potential risks associated with injecting this unauthorized product may include infection at the site of injection and sepsis (blood poisoning). Patients with liver or kidney impairment may experience complications, including increased ammonia levels in the blood, fluid and electrolyte imbalance, impaired consciousness and even coma.
Liporase is a product labelled to contain hyaluronidase. Products containing hyaluronidase are used in ophthalmic surgery and are reportedly also used experimentally in some countries to manage complications from cosmetic procedures. The potential risks associated with injecting a hyaluronidase product can include redness of the skin, irregular heartbeat, confusion and blurred vision. Additionally, serious side effects can occur when certain medicines are used together with hyaluronidase.
Sodium Chloride 0.9% is a fluid and electrolyte replacement product. Potential risks associated with injecting this unauthorized product may include infection at the site of injection or sepsis. Patients with heart failure, kidney failure or liver failure who receive this product may be at increased risk for fluid and electrolyte imbalances.
J-CAIN is labelled to contain lidocaine. Lidocaine cream is considered safe when used in small amounts and low concentrations over small areas of the body. However, this cream is labelled to contain a 15.6% concentration. Health Canada has not done a safety review of creams containing lidocaine at a high concentration. When 15.6% lidocaine cream is applied on the body, a significant amount of lidocaine may be absorbed into the bloodstream, which may cause the buildup of toxic levels of lidocaine in the body. The toxicity of lidocaine can be local or systemic. Symptoms of local toxicity may include redness, itching, burning and swelling in the application area. Systemic toxicity most often affects the central nervous system or the cardiovascular system. Severe symptoms of systemic toxicity may include irregular heartbeat, difficulty breathing, seizure, coma and death.
For more information
Stay connected with Health Canada and receive the latest advisories and product recalls using social media tools.
To learn more about natural health products and other self-care products, visit Canada.ca/selfcare-products.
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SOURCE Health Canada
