What is a Recall?

With respect to a health product other than a medical device, it means a firm's removal from further sale or use, or correction, of a distributed product that presents a risk to the health of consumers or violates legislation administered by the Health Products and Food Branch.

In the Medical Devices Regulations a recall is defined as: any action taken by the manufacturer, importer or distributor of the device that has been sold, to recall or correct the device, or to notify its owners and users of its defectiveness or potential defectiveness, after becoming aware that the device:

1. may be hazardous to health;
2. may fail to conform to any claim made by the manufacturer or importer relating to its effectiveness, benefits, performance characteristics or safety; or
3. may not meet the requirements set in the Act or the Regulations.

Definitions

Drug Identification Number (DIN)

A DIN is an eight (8) digit numerical code assigned to each drug product marketed under or in accordance with the Food and Drugs Act and Regulations.

Natural Product Number (NPN)

Is an eight digit numerical code following the acronym NPN assigned to each natural health product approved to be marketed under the Natural Health Products Regulations.

Homeopathic Medicine Number (DIN-HM)

Is an eight (8) digit numerical code following the acronym DIN-HM assigned to each homeopathic medicine approved to be marketed under the Natural Health Products Regulations.

Hazard Classification

The numerical designation, i.e., Type I, II, or III, assigned by Health Products and Foods Branch (the Branch) to a particular product to indicate the relative degree of health hazard presented by the product, as follows:

• Type I: a situation in which there is a reasonable probability that the use of, or exposure to, a product will cause serious adverse health consequences or death,
• Type II: a situation in which the use of, or exposure to, a product may cause temporary adverse health consequences or where the probability of serious adverse health consequences is remote, or
• Type III: a situation in which the use of, or exposure to, a product is not likely to cause any adverse health consequences.

Type I and II include situations where a product which does not have generally recognized or supported therapeutic value is promoted in such a way that avoidance of recognized therapy occurs and where such avoidance could lead to injury or death.