Advisory - Unauthorized injectables and other health products from Galena Pharm Inc. pharmacy may pose serious health risks

OTTAWA, ON, Feb. 12, 2021 /CNW/ -

Summary

• Products: Unauthorized health products from Galena Pharm Inc. pharmacy, including vitamins, minerals, amino acids, naturopathic cancer therapy and other therapies administered by injection or infusion in health settings, such as clinics, and non-injectable products such as capsules and suppositories that patients may have in their homes.
• Issue: These products are unauthorized and may pose serious health risks. For example, one injectable product called reduced glutathione was found to contain high levels of endotoxin, a harmful substance produced by bacteria.
• What to do: Health care practitioners should stop administering and selling these products, and patients should stop using them after confirming with their health care practitioner. Patients should consult their health care practitioner if they have questions about whether they have received treatment using a Galena Pharm Inc. product and have questions or concerns about their health.

Issue
Health Canada is warning health care practitioners and patients that unauthorized health products prepared and sold by Galena Pharm Inc. pharmacy (4315 Canada Way, Burnaby, B.C.) may pose serious health risks. Health care practitioners and patients should stop administering or using them.

Products include vitamins, minerals, amino acids, naturopathic cancer therapy and other therapies administered by injection or infusion in health settings, such as clinics, and non-injectable products such as capsules and suppositories that patients may have in their homes. They were sold to health care practitioners (including naturopaths and physicians) in at least three provinces: B.C., Alberta and Ontario.

Health Canada directed the pharmacy to recall one product, reduced glutathione for injection, due to reports of endotoxin poisoning in B.C. Health Canada testing confirmed high levels of endotoxin. Endotoxin is a harmful substance produced by bacteria. Exposure to high levels of endotoxin in the blood can cause serious health problems, such as fever, nausea and vomiting, low blood pressure, shock, organ failure, and death. This risk is especially high when contaminated products are injected or infused into the body.

Health Canada also directed the pharmacy to stop manufacturing and selling all unauthorized health products. Unauthorized health products have not been approved by Health Canada, which means that they have not been assessed for safety, effectiveness and quality. Selling unauthorized health products in Canada is illegal. 

In addition, Galena Pharm Inc. was found to be operating without the necessary Health Canada drug establishment licence. Operating without the required licence is a serious contravention of the Food and Drugs Act and its regulations. Licensing indicates that a company has processes in place that meet regulatory requirements to enable the company to rapidly track and recall its health products. It also indicates that the company is manufacturing, packaging and labelling products using Good Manufacturing Practices (a standard that aims to ensure the quality of health products sold to Canadians).

The pharmacy is now closed and its owner is currently under investigation by the College of Pharmacists of British Columbia.

Health Canada will continue to monitor the effectiveness of the recall and work with the College of Pharmacists of British Columbia as needed. Health Canada is also working closely with the Canada Border Services Agency to monitor importation related to Galena Pharm Inc. If additional safety concerns are identified, Health Canada will take action and inform Canadians.

Affected products

Below is a product list that Galena Pharm Inc. was advertising to health care practitioners. This may not be a complete list of products sold by the company. None of these products are authorized by Health Canada.

What you should do
Health care practitioners should:

• Check their stock to verify if they have products from Galena Pharm Inc. and stop administering or selling them.
• Verify that the products they are administering or selling are authorized by Health Canada by reading the label. Authorized health products have an eight-digit Drug Identification Number (DIN), Natural Product Number (NPN) or Homeopathic Drug Number (DIN-HM). Practitioners 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 any health product adverse events or complaints to Health Canada.

Patients should:

• Stop using products prepared by Galena Pharm Inc. after confirming with their health care practitioner.
• Contact their health care practitioner if they have questions regarding whether they have received treatment using a Galena Pharm Inc. product (injectable or any other format) and have questions or concerns about their health.
• 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). Patients 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 any health product adverse events or complaints to Health Canada.

Related links:

• Recall Notice (Jan 21, 2021): 30ml Reduced Glutathione 200mg/ml
• College of Pharmacists of B.C. Notice (Dec 30, 2020): Galena Pharm Inc. owner's practice under investigation
• Recall Notice (Nov 13, 2020): 30ml Reduced Glutathione 200mg/ml

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SOURCE Health Canada