Advisory - Pharm Canada Inc. recalls all lots of "Passion X" and "Passion Fem" because they contain an undeclared prescription drug ingredient and may pose serious health risks

OTTAWA, October 9, 2019 /CNW/ - Health Canada is advising Canadians that Pharm Canada Inc. is recalling all lots of "Passion X" and "Passion Fem" from retail because they contain an undeclared prescription drug ingredient (sildenafil) and may pose serious health risks. The products are marketed to help support emotional aspects of sexual health.

Passion Fem 2 Capsules – Front (CNW Group/Health Canada)

Passion Fem 10 Capsules – Front (CNW Group/Health Canada)

Passion Fem – Back (CNW Group/Health Canada)

In addition, Health Canada suspended all of the company's sexual health product licences, which means no person or company is permitted to sell these products in Canada (see affected products below). Pharm Canada Inc. confirmed "Passion X" and "Passion Fem" are the only sexual health products it was marketing in Canada.

Prescription drugs should be taken only under the advice and supervision of a health care professional because they are used to treat specific diseases and may cause serious side effects.

Who is affected

• Consumers who have bought or used sexual health products sold by Pharm Canada Inc.

Affected products

• All lots of Passion X (NPN 80077712), available in packages of 2 capsules and 10 capsules
• All lots of Passion Fem (NPN 80087293), available in packages of 2 capsules and 10 capsules

Suspended product licences:

Product name(s)	Suspended NPN
Passion X	80064558
Zoro	80077616
Vigor X	80077708
Performax X	80077711
Passion X; Bio Power X	80077712
Natura-One Passion Fem; Passion Fem	80087293
Passion Xtra; Horny Bull	80088477

What consumers should do

• Stop using the affected products. Consult your health care professional if you have used any of these products and have health concerns.
• Return any unused product to the place of purchase.
• Contact Pharm Canada Inc. at [e-mail] or 416-255-5555 ext. 222 if you have questions about the recall.
• Report any health product-related adverse reactions or complaints to Health Canada.

What Health Canada is doing
Health Canada has suspended the company's licences for sexual health products, which means that these products cannot be sold in Canada. Health Canada is completing product testing and is monitoring the company's recall of Passion X and Passion Fem. Should additional safety concerns be identified, Health Canada will take appropriate action and inform Canadians as necessary.

Background

Sildenafil is a prescription drug used to treat erectile dysfunction and should be used only under the supervision of a health care professional. It should not be used by people who are allergic to it. As well, it should not be used by individuals taking any kind of nitrate drug (e.g., nitroglycerine) as it can cause potentially life-threatening low blood pressure. Individuals with heart problems are at increased risk of cardiovascular side effects such as heart attack, stroke, chest pain, high blood pressure and abnormal heartbeat. Other possible side effects include headache, facial flushing, indigestion, dizziness, abnormal vision, and hearing loss.

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SOURCE Health Canada

For further information: Media Enquiries: Health Canada, [phone], [e-mail]; Public Enquiries: [phone], 1-866 225-0709