"Jian Pai Natural Skin Care Cream" contains antifungal drugs not listed on the label, which may pose serious health risks

Starting date:

August 2, 2018

Type of communication:

Advisory

Subcategory:

Drugs, Natural health products

Source of recall:

Health Canada

Issue:

Important Safety Information

Audience:

General Public

Identification number:

RA-67362

• 
  Issue
• 
  Products affected
• 
  What you should do
• 
  Who is affected
• 
  Background
• 
  Media enquiries
• 
  Public enquiries
• 
  What Health Canada is doing
• 
  Images

Issue

Health Canada testing of “Jian Pai Natural Skin Care Cream,” also called ‘’Yikangshuang,” found that it contains two antifungal drugs (fluconazole and miconazole) that are not listed on the product label, and may pose serious health risks.

Products affected

• Jian Pai Natural Skin Care Cream (NPN 80038015)

What you should do

• Do not use this product. Consult with your healthcare professional if you have used it and have health concerns.
• 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.

Who is affected

• Consumers who have bought or used this product, particularly pregnant or breastfeeding women and people taking blood-thinning medication.

Background

Fluconazole is available by prescription and over the counter for the treatment of various fungal infections. It is taken only orally (by mouth) or by intravenous injection, and is not approved for use on the skin. Side effects associated with the use of intravenous and oral fluconazole include heart rhythm problems, kidney disease, liver disease, and severe skin reactions. Fluconazole should not be used by pregnant or breastfeeding women. As well, when not used as directed, fluconazole could increase the risk of fungal-resistant infections.

Miconazole is a non-prescription drug used for the treatment of various fungal infections. Side effects associated with topical use (applied on the skin) include itching, irritation, and burning at the application site. Side effects associated with products for vaginal use include burning, itching, irritation, pelvic cramping and swelling, as well as hives, rash and headache. Unless directed by a healthcare professional, miconazole should not be used by pregnant or breastfeeding women. It also should not be taken with blood-thinning medications (such as warfarin) unless on the advice of a heath professional, as bruising and bleeding may occur.

Media enquiries

Health Canada

(613) 957-2983

Public enquiries

(613) 957-2991

1-866 225-0709

What Health Canada is doing

Jian Pai Natural Skin Care Cream is not authorized to contain fluconazole or miconazole; Health Canada has therefore suspended its license. This means the product can no longer be sold legally.

Health Canada has also requested that the importer, Canada Orient International Trade Inc., stop selling and recall the product.

Should additional safety information become available, Health Canada will take appropriate action and inform Canadians as necessary. If consumers find this product on store shelves, they are asked to contact Health Canada to file a complaint, using the contact information provided above.

Images

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