Advisory - Product licence suspended for Perfect Sports Core Series Pure Creatine; all lots recalled

OTTAWA, ON, March 5, 2021 /CNW/ -

Summary
Product: Perfect Sports Core Series Pure Creatine (also known as Creatine Powder, NPN 80012948)
Issue: Health Canada has suspended the product licence, which means the product can no longer legally be sold. All lots are being recalled due to potential safety issues.
What to do: Stop using the product. Talk to a health care professional if you have used this product and have health concerns.

UPDATE: March 5, 2021
Health Canada has suspended the product licence of Perfect Sports Core Series Pure Creatine (also known as Creatine Powder) (NPN 80012948) as a result of the vitamin D contamination of Lot 2006CRTN807 and because of non-compliance with Good Manufacturing Practices (GMPs). The product label is also missing the statement "for adult use only". The product licence suspension means that the product can no longer legally be sold. Health Canada has directed the company to recall all remaining lots from the market.

In addition, Health Canada has suspended the company's site licence, which means that Genex Nutraceuticals can no longer manufacture, package or label natural health products. This prohibition will remain in place until the company can demonstrate that it can meet the regulatory requirements, which are necessary to protect health and safety of consumers.

A site licence indicates that a company has been assessed for and is able to manufacture, package and label natural health products according to Good Manufacturing Practices (a standard that helps ensure the quality of health products sold to Canadians). It also indicates that a company has processes in place that meet regulatory requirements for tracking and recalling health products when necessary.

Health Canada is advising retailers to stop selling this product and consumers to stop using it. Consult your health care professional if you have used it and have health concerns. Report any health product adverse events or complaints to Health Canada.

Health Canada will monitor the effectiveness of the company's recall and take additional action as needed to mitigate any risks to Canadians.

Original Advisory: February 21, 2021 - Recall of one lot of Perfect Sports Core Series Pure Creatine (also known as Creatine Powder) due to dangerous levels of Vitamin D contamination

Health Canada is advising Canadians that Genex Nutraceuticals is recalling one lot (2006CRTN807) of its Perfect Sports Core Series Pure Creatine (also known as Creatine Powder) (NPN 80012948) due to the presence of Vitamin D in the product. This product is not authorized to contain vitamin D.

Vitamin D is considered a prescription drug when taken orally (by mouth) at doses of more than 1,000 International Units (IU) per day.

Too much vitamin D can lead to vitamin D "intoxication," which can cause weakness, fatigue, drowsiness, headache, lack of appetite, dry mouth, metallic taste, nausea, vomiting, vertigo, ringing in the ears, lack of coordination, and muscle weakness. Pregnant women in particular should not take vitamin D exceeding the daily tolerable upper intake level for adults (4,000 IU). High levels of vitamin D taken during pregnancy can potentially lead to high calcium levels in the pregnant woman, which can be associated with risks to the newborn.

What Health Canada is doing
Health Canada will monitor the recall and any necessary corrective and preventative actions taken by Genex Nutraceuticals. If new health risks are identified, Health Canada will take appropriate action.

What you should do

• Stop using the product and return it to the store where you purchased it.
• 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.
• Report any health product adverse events or complaints to Health Canada.

SOURCE Health Canada