Ginseng Blood Pressure Pills (May 08, 2007)

Starting date:

May 08, 2007

Posting date:

June 11, 2007

Type of communication:

Drug Recall

Subcategory:

Natural health products

Hazard classification:

Type II

Source of recall:

Health Canada

Issue:

Product Safety

Audience:

General Public, Healthcare Professionals, Hospitals

Identification number:

RA-2007A34

• Reason
• Depth of distribution
• Affected products

Reason

A risk analysis conducted by the NHPD concluded that in accordance with the Compliance Policy for NHPs, Ginseng Blood Pressure Pills, an unlicensed NHP, has met the following risk criteria for which the Inspectorate has requested Wing Quon for an immediate stop sale and advertising and to initiate a recall to retail level. 1. Contains a prohibited or restricted substance: One of the ingredients, Radix Stephaniae tetradae has been known to have been substituted by Aristolochia fangchi, which contains aristolochic acid (AA). Ingestion of AA may lead to serious adverse health consequences. Health Canada has issued a "Warning" on Nov. 3, 1999 advising consumers not to use products containing AA. 2. Makes claims with respect to serious diseases: Package insert makes Schedule A health claim indications related to hypertension, coronary heart disease and myocardial infarction and is in violation of Section 3 of the FDA. 3. Not labelled with adequate information to allow the product to be used safely: Inadequacies of the outer and inner label include the absence of the cautionary statement, "Do not use if pregnant or breastfeeding", the absence of the importer's name and address, lack of an expiration date and lot number.

Depth of distribution

Distribution to Canadian retailers in Vancouver, Edmonton, Calgary, Toronto and Montreal. No Exports.

Affected products