Recalling Consumer Products - A Guide For Industry

April 2005

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This guide is intended to assist you as an importer, manufacturer, distributor, wholesaler, or retailer of consumer products to complete an effective recall of unsafe consumer products from the marketplace. Some companies may have well-developed systems for tracking products and conducting recalls. This guide covers the basic steps to removing unsafe products quickly and completely from the market. Health Canada's Product Safety Officers in your area may be contacted to provide further advice and guidance.

What is a Recall?

A consumer product recall is the removal from distribution, sale, or consumer use of a product that does not comply with legislation in Canada, or poses an unacceptable risk to the health and safety of consumers or users of the product.

Why Recall?

The recall of a consumer product will:

• minimize the risk of injury or death to consumers by removing the unsafe product from use;
• retrieve as many defective products from the marketplace as possible; and
• minimize the cost and inconvenience to consumers, your customers, and your company.

When to Recall?

Persons importing, manufacturing, advertising, or selling consumer products in Canada must ensure that their products comply with the applicable requirements of the Hazardous Products Act and Regulations or the Cosmetic Regulations under the Food and Drugs Act. Companies also have a responsibility to ensure that unregulated products that they import, advertise, or sell are safe for consumer use.

In most cases, a company should initiate a product recall when they become aware:

• of a defect that makes a product unsafe;
• of an injury or death to consumers caused by an unsafe product; or
• that a product does not comply with legislative requirements.

Health Canada's Consumer Product Safety Program enforces the Hazardous Product Act and Regulations, and the Cosmetic Regulations under the Food and Drugs Act. Health Canada may request that a company initiate a recall when:

• a product does not comply with the applicable legislation; or
• a product poses an unacceptable risk to the health and safety of the consumer or user.

How to Complete a Product Recall?

Step 1: Getting Started

Choose a qualified person on your staff with sufficient authority to coordinate the recall. This person should ensure that the steps of the recall are completed by your staff. The recall coordinator may also act as the contact person to relay information to Health Canada about the recall.

Step 2: Identify all Products to be Recalled

Ensure that all products that need to be recalled are identified. In addition to those products directly affected by the problem, you must:

• determine if any other codes, brands or sizes of the same product are affected; and
• determine if any other products are affected.

Information to identify each product affected by the recall may include the description, style, colour, brand, UPC code, lot number, item number, date of manufacture or date of import.

Step 3: Isolate Warehouse Stock of the Products to be Recalled

Identify and clearly mark stock of recalled products located in your warehouse or other storage facilities. These products should be isolated from other stock to prevent distribution.

Step 4: Track the Products That Have Been Distributed

Produce a distribution list using your product distribution records which:

• identifies the accounts that received the recalled product;
• lists the business name, address, contact name and telephone number for each account; and
• identifies the type of account e.g., wholesaler, distributor, retailer.

This task is made easier if your computer system or invoicing system is set up to allow you to sort and find customers who have purchased specific items.

This distribution list identifies all accounts who must be notified of the recall. Health Canada Product Safety Officers will require a copy of this list to assist in monitoring the effectiveness of the recall.

Step 5: Determine the Action That Your Accounts Must Take

Instruct accounts to remove the product from sale immediately. Determine whether the recalled products will be repaired, replaced, or destroyed. Determine whether accounts will be instructed to return the recalled products to your warehouse or other location.

Step 6: Prepare and Distribute the Recall Notice to Your Accounts

Prepare a bilingual recall notice and distribute to all your accounts who have purchased the recalled products (see Step 4). The recall notice should include:

• "Urgent - Product Recall" heading
• date the recall notice is sent to accounts
• product identity (includes brand, UPC, lot number, item number, description, etc. and a picture if possible)
• reason for the recall, including a statement of the hazard and associated risk
• request to immediately remove the product from sale
• recall action to be completed by the account (remove from sale, instructions for arranging return, etc.)
• request that a recall be initiated by any accounts who have further distributed the product
• name and contact number at your company to call for more information
• date that recall action is to be completed by the account
• a statement that the recall will be monitored for compliance by Health Canada

The recall notice may be distributed to your accounts by fax, e-mail, telephone, or other method. A copy of this notice should be provided to a Health Canada Product Safety Officer for review prior to distribution.

Note that Health Canada may post an advisory and recall notice on its website.

Step 7: Check the Effectiveness of the Recall

Follow-up with your accounts to be sure that they have:

• received the recall notice;
• removed the products from sale; and
• completed the recall action as specified in the notice.

Step 8: Notifying Consumers

Action may be necessary to quickly notify consumers if unsafe products are in the Canadian marketplace. Advise consumers of the product hazard and the action they should take to minimize the risk of injury. To warn consumers, your company may produce and distribute a media release, newspaper advertisement, display signs or point of sale posters to display in retail outlets where the recalled products were sold, and/or post the recall on your company website. Any form of publicity should be issued in both English and French. A recall media release may include the following information:

• name and location of the recalling company
• a detailed description of the product, including name, make, model, distinguishing features, batch or serial number, retail cost, etc.
• a statement of the hazard and associated risk
• the number and type of injuries reported
• dates when the product was available for sale
• retail locations where the product was sold
• the number of products involved
• the immediate action that the consumer should take
• who consumers should contact for further information including a telephone number, preferably toll-free with service in English and French, and hours of business
• a picture of the product

If sales were made directly to consumers and a customer database is available, consumers can be notified directly about the recall.

Step 9: Decide What to Do with the Returned Products

Correct and dispose of recalled products in a way that will ensure that unsafe products do not make their way back into the Canadian marketplace. Disposal of products must be carried out in a manner that is in compliance with municipal and provincial waste disposal requirements. If products are repaired or corrected, verify compliance with regulatory requirements before they are redistributed. Make sure that the repaired or corrected products can be distinguished from the recalled products.

Step 10: Report Back to Health Canada

Report the number of recalled units identified by your accounts to a Health Canada Product Safety Officer and include a summary of the actions taken to return, repair, or destroy all of the recalled products.

Step 11: Recall Monitoring by Health Canada

Health Canada will follow up with some of your accounts to verify the effectiveness of the recall. If it is determined that the recall was not effective and unsafe products remain on the market, you may be required to repeat the recall process. Further action may be taken by Health Canada including issuing a public warning about the problem, and prosecution for failure to comply with regulatory requirements.

Step 12: Fix the Cause of the Recall

It is your responsibility to ensure that all reasonable steps are taken to prevent similar recalls in the future. Know the regulatory requirements for the products that you manufacture, import, advertise or sell. Have regulated products tested, or ask suppliers to provide test reports to verify compliance with the Hazardous Products Act and Regulations or the Cosmetic Regulations under the Food and Drugs Act. Consult the Health Canada website or your nearest Product Safety Office for information on regulated and unregulated product hazards.