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Unauthorized injectables and other health products from Galena Pharm Inc. pharmacy may pose serious health risks – Recalls and safety alerts

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

Summary

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.

Vitamins injections

Minerals injections

Amino acids and cofactors injections

Naturopathic oncology

Chelation therapy injections

Prolotherapy injections

Mesotherapy injections

Weight loss injections

Other injections

What you should do

Health care practitioners should:

Patients should:

This content was originally published here.

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