Recall Plans - Importers' Guide

This page is part of the Guidance Document Repository (GDR).

Looking for related documents?
Search for related documents in the Guidance Document Repository

1.0 Introduction

What is a food recall?

Food manufacturers use many controls to make sure that the products they produce are safe. Sometimes, for many different reasons, a product may be manufactured and sold which may make some people ill or injure them, or is in violation of the legislation. When an unsafe or violative food product has left the control of the manufacturer, it must be removed from the market. This process of removing the product is called a "recall". If your firm has imported a product which is unsafe or violative and you have sold the product to someone else, you must recall the product. If you choose not to conduct a recall, the Minister of Agriculture may order you to conduct the recall under Section 19 of the Canadian Food Inspection Agency Act. This applies to all firms importing food products into Canada.

What is the goal of this guide?

Ask yourself these questions.

  • "If you needed to remove a product from the market right now, would you be able to do it?"
  • "Would you be able to remove the product quickly?"
  • "Would you be able to remove all of the product?"

The goal of this guide is to provide you with an overview of how to develop a recall plan and how to action that plan in the event of a recall. It will assist you in identifying unsafe products which you have received and sold.

2.0 Make an Recall Plan

Recalling a product is a planned action. This section of the guide describes how your firm can develop a written recall plan prior to having a recall. This will help you remove unsafe or violative product(s) which your firm has imported and sold, from the market quickly and efficiently.

There are nine basic elements which should be included in your recall plan. All of these elements must be included; each element plays a specific role and provides a different benefit to your firm.

1. Recall Management Team

Benefits

When an unsafe food product has been identified it must be removed from the market quickly. Identifying persons in your firm and assigning recall duties to each person will allow you to action your recall plan smoothly. You can be assured that all of the procedures are covered. Also, many recalls happen after regular work hours so you must be prepared to contact people outside of the office/plant. The list of people who make up your team should be reviewed and updated on a regular basis.

Description

Your team should include people responsible for:

  1. Decision making
  2. Quality assurance / technical advisory
  3. Media communication
  4. Complaint investigation
  5. Contacting accounts
  6. Contacting the CFIA
  7. Legal Counsel

Your recall management team document should include the following:

Recall Management Team
This table shows the following information your recall management team document should contain.
NameAlternate PersonBusiness PhoneAfter Hours PhoneResponsibilities during Recall
Person's name and position in the firm a replacement individual in the event that the person is not available the duties of the person during a recall

2. Complaint File

Benefits

If you receive a complaint, it is important to record the complaint information, complete an investigation at your storage facility, and contact the CFIA. Early action on your part may enable you to discontinue distributing the product until it is determined that the product is safe.

Description

There are three main parts to the complaint file:

  1. Recording of the initial complaint information
  2. Investigation at your storage facility
  3. Action taken for the specific product

Recording of the Initial Complaint Information

The complaint should be recorded by a designated individual(s). It is important to include enough information so that the manufacturer of the product can start an investigation of the problem immediately. This may include but is not limited to:

1. Complainant details

  • name, address, telephone number (s) of the complainant

2. What is the problem with the product, e.g. chemical taste, allergic reaction, illness, object in the food

3. Product details

  • package type and size
  • product name
  • identifying codes
  • does the complainant have a sample of the product?

4. Retail Details

  • name and address of store
  • date of purchase

5. Illness and Injury Details

  • when was the product consumed (date and time)
  • has the product been consumed before
  • number of persons consuming the product
  • number of person(s) ill
  • names and ages of the person(s) ill
  • amount of product consumed
  • time the person(s) became ill
  • symptoms of illness in order of occurrence
  • physician consulted / physician name, contact number, date of contact
  • current status of illness
  • description of injury
  • current status of injury

6.Has the complaint been referred to anyone else?, e.g. the Canadian Food Inspection Agency or Public Health

Investigation at the Storage Facility

It is important when you receive a complaint to make sure that the problem with the product did not result from activities at your storage facility. Investigate the complaint fully. If you determine that the problem was caused by activities in your storage facility, contact the CFIA immediately.

Record in your complaint file:

  • the name of the person at your firm who investigated the complaint
  • date and time of the investigation
  • investigation findings
  • other products which may be affected by the problem

Complaint Referral

If you determine that the problem was not caused at your storage facility, refer the complaint immediately to the manufacturer who produced the product.

Record in your complaint file:

  • the name of the person at your firm who referred the complaint to the manufacturer
  • the name of the person contacted at the manufacturing or importing firm
  • date and time of the referral

Action Taken

Although the problem with the product may have been caused at the manufacturing plant outside of Canada, it is your responsibility to determine the action to be taken with the product. Where the problem could be of a health and safety concern, you must contact the Canadian Food Inspection Agency to ensure that your action decision is correct. Once the decision has been made you should record:

  • what the action is, i.e., recall, no recall
  • instructions to give to your accounts regarding the disposition / return of the product

3. Recall Contact List - Canadian Food Inspection Agency (CFIA) Notification

Benefit

If you suspect that you have distributed an unsafe food product, contact the CFIA immediately. The CFIA staff can assist you with your investigations and should be consulted on all health and safety corrective action decisions. Each area in the CFIA has a Recall Coordinator who will assist you in contacting CFIA staff to help you with your investigation and the collection of the information necessary to make the most appropriate decision.

4. Tracing of Products

Benefits

Being able to identify which product(s) have to be recalled is a great benefit to your firm. It allows you to limit the scope of the recall and remove the product(s) from distribution quickly and accurately. If you cannot identify a specific product(s) you may have to recall more product than is necessary. Furthermore, incorrect identification of all of the product during the first recall, may lead to other recalls. To do this, you must be able to trace the products that you have received and distributed.

Description

To limit your recall to a specific product(s) you must:

  1. Link the products you have received to each supplier
  2. Distribution Records - link the products you have received to the accounts you have distributed the product to. This is a separate element in your recall plan.

Receiving Records

All products that you receive, should be identified with a specific lot code. You should have a system in place which identifies and records the lot codes of each product you have received from each supplier.

For each supplier you should document:

  • the definition of a lot for each product
  • the parts and interpretation of the code(s) (obtained from the supplier)
  • a description of the system you are using to link the lot codes from the supplier to your shipping records

5. Distribution Records and Distribution Record System

Benefit

When the product is being shipped out of your storage facility into the distribution system, the lot codes of each product should be linked to the accounts receiving that product. This completes the link of the product from supplier - to your firm - to the accounts. Keeping this link is important; it enables you to limit your recall to the specific accounts that received the product being recalled. Your firm should have a record system which can generate these records accurately and quickly.

Description

Your firm should be able to create a distribution list which is product and lot code specific.

This distribution list should include:

  • name of the account, street address, city, province
  • the product name and lot code
  • the type of account, for example: manufacturer (if you are distributing a product which is used in the manufacturing of another product), distributor, retailer
  • who to contact at the account
  • telephone number and other contact numbers consistent with the documented method of contact during a recall, e.g. fax number, e-mail address
  • amount of product shipped to each account

These distribution records should be kept for a period of time that exceeds the shelf life of the product. In some instances the period of time is specified in CFIA inspection manuals or by regulations. Check with the CFIA to ensure that you are maintaining your distribution records for the correct period of time.

6. Recalled Product Records

Benefit

For your own protection, keep records of products that you have recalled from your accounts.

Description

Your recalled product records should contain:

  • a description of the product recalled: brand and product name, size, identifying codes
  • the amount of product recalled
  • the date the product was recalled
  • what you did with the product, for example, returned to the supplier, destroyed

7. Recall Procedures

Benefit

There are several activities which happen simultaneously during a recall. Having a step-by-step recall procedure will ensure that all of the activities are completed. This is the plan that you will action during a recall. A brief description of each of the recommended steps is included below. Further details on the parts of each step and how to action your plan are described in Tab 3 of this guide.

Description

The recommended step-by-step procedure is as follows:

  1. Assemble the Recall Management Team
  2. Notify the CFIA
  3. Identify all products to be recalled
  4. Detain and Segregate all products to be recalled which are in your firm's control
  5. Prepare the Press Release (if required)
  6. Prepare the Distribution List
  7. Prepare and distribute the Notice of Recall
  8. Verify the effectiveness of the recall
  9. Control the recalled product(s)
  10. Decide what to do with the recalled product(s)
  11. Fix the cause of the recall if the problem occurred at your facility

8. Recall Effectiveness Procedures

Benefits

Your firm is responsible for ensuring that all of the accounts which you shipped the recalled product to are notified about the recall. You must assess the effectiveness of your notification. The actual process of how to notify accounts is described in Tab 3 of this guide.

Description

The recall effectiveness procedure includes a plan to assess the effectiveness of the recall. Elements of the plan should include:

  • the number of accounts that were notified of the recall
  • the number of accounts that were contacted or checked to see if they had received the recall notification
  • method of confirming that the accounts were notified
  • a statement describing how you determine if your recall notification was effective
  • a statement of the recall notification effectiveness, i.e., satisfactory, not satisfactory
  • a statement of the corrective action to be taken where it is determined that the recall was not satisfactory

9. Testing Your Recall Plan

Benefit

During a recall, your firm's recall management team will be busy putting your recall plan into action. This is not the time to find out that your recall plan is not working or that the plan does not provide the information you need to remove the unsafe product from the market completely and quickly. Testing your recall plan before you have to do a recall, enables you to identify and correct problems in your plan.

Description

Your recall plan should be tested on a regular basis.

When you test your recall plan, pick a lot code of a product which you know has reached the consumer market. Then test your system and record:

  • a description of the test scenario, for example: "An investigation resulting from a consumer complaint of a problem with "Product AA" determined that the product was contaminated and that the product should be removed from the market immediately"
  • the date of the test
  • problems you identified during the test
  • for each problem you identified during the test, how you changed the recall plan to correct the problem.

3.0 Action Your Recall Plan - Steps to an Effective Recall

Introduction:

Tab 2 of this guide described how your firm can develop a written recall plan prior to having to conduct a recall. These written elements form the basis for:

  • identifying health and safety concerns in your existing food safety systems
  • contacting and working with CFIA staff
  • assigning recall duties to specific individuals in your firm to ensure that all parts of the recall are covered
  • tracing and identifying products which are affected by the problem
  • tracing product shipments
  • controlling returned product
  • checking the effectiveness of your recall
  • testing your written recall plan to ensure that it is efficient and effective.

All of these elements should be developed and documented prior to conducting a recall.

The goal of this section of the guide is to describe, in detail, each of the key steps your firm should take once it has been decided that a recall will be conducted. These recommended steps include the preparation of a Notice of Recall, and in some circumstances, a press release. Your firm should review these sections prior to conducting a recall so that you will be familiar with the document requirements and their purpose. It would be beneficial for your firm to maintain "templates" or to prepare sample documents that can be used as examples during a recall. This will speed up the process and ensure that all of the necessary information is included.

The recommended steps of conducting a recall are as follows:

Decision to Recall the Product(s)

  1. Assemble the Recall Management Team
  2. Notify the CFIA
  3. Identify all products to be recalled
  4. Detain and Segregate all products to be recalled which are in your firm's control
  5. Prepare the Press Release (if required)
  6. Prepare the Distribution List
  7. Prepare and distribute the Notice of Recall
  8. Verify the effectiveness of the recall
  9. Control the recalled product(s)
  10. Decide what to do with the recalled product(s)
  11. Fix the cause of the recall is the problem occurred at your facility

Problem identification / Decision to recall product(s)

Problems resulting in a recall may be identified by the importer, consumers or the CFIA. Once a product has been identified as being unsafe or violative, it is your firm's responsibility to determine the nature and extent of the problem in a timely manner and to take prompt and appropriate action to protect the health of consumers. Where the problem is of a health and safety concern, you must consult with the Canadian Food Inspection Agency to ensure that your action decision is correct.

Step 1: Assemble your recall management team

At the very beginning of the recall your firm must:

  • Make sure all members of the recall management team are informed of the decision to conduct a recall
  • Ensure that each member knows their responsibilities during the recall

Step 2: Notify the CFIA

Notify the CFIA immediately when you suspect that your firm has imported and sold a product that may pose a serious risk to consumers. Provide the CFIA with the following information:

  • a detailed description of the nature of the problem
  • the name, brand, size, lot code(s) affected
  • details of complaints received and any reported illnesses
  • the distribution of the product - local or national
  • when the product was distributed (specific dates)
  • label(s) of the product(s) which may be recalled
  • the total quantity of product imported and distributed
  • the name of your firm's contact with the CFIA
  • the name and telephone number(s) for your firm's after-hours contact

This information is pertinent for the CFIA to develop an accurate and complete risk management strategy.

Step 3: Identify all products to be recalled

It is your firm's responsibility to ensure that all products which need to be recalled are identified. In addition to those products directly affected by the problem, your firm must:

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

Step 4: Detain and segregate products to be recalled which are in your firm's control

It is your firm's responsibility to ensure that products to be recalled that are in your firm's control are not distributed. Your firm must:

  • determine the locations of the recalled product(s) e.g. on-site, at the plant, off-site storage
  • determine the amounts at each location
  • identify and segregate products to prevent distribution

Step 5: Prepare the press release (if required)

The purpose of a press release is to alert the public that a product presents a serious hazard to health. Not all recalls require a press release; the CFIA will advise you when a press release is necessary. Where the CFIA is not in agreement with a press release prepared by your firm, the CFIA may issue a separate press release. An example template is provided in Appendix A. In addition, examples of press releases are available on the CFIA website at: www.inspection.gc.ca.

During this step, your firm must:

  • decide who will prepare the press release, your firm or the CFIA
  • if your firm decides to prepare the press release, include all relevant information (see template, Appendix A)
  • complete the press release within two hours after being notified of the recall
  • submit a draft of the proposed Press Release to the CFIA for approval
  • arrange for translation of the press release

Step 6: Prepare the Distribution List

Using your distribution record system, produce a product and lot code specific distribution list which:

  • identifies the accounts that received the recalled product
  • lists the accounts names and addresses, contact names and telephone numbers
  • identifies the type of account e.g., manufacturer, distributor, retailer

Provide the distribution list to your CFIA contact within 24 hours.

Step 7: Prepare and Distribute the Notice of Recall

Your firm is responsible for immediately notifying all of the accounts that received the recalled product.

  • content of notice- prepare a written notice which includes all relevant information (see template, Appendix B)
  • confirmation of receipt/ action - ask customers to confirm that the notice has been received and action has been taken
  • approval of notice - submit the draft notice to CFIA for approval. Where a Notice of Recall contains inaccurate information and/or is incomplete, the CFIA may require your firm to revise the Notice and reissue it.
  • method of transmission- Transmit your Notice of Recall to your accounts by the method stated in your distribution records system, e.g. fax, telephone, e-mail
  • follow-up - contact customers who have not responded to your request for confirmation of receipt of the Notice of Recall
  • record-keeping - keep records of those accounts which your firm has contacted and which accounts have confirmed that they have received the Notice of Recall

Step 8: Verify the Effectiveness of the Recall

  • verify that your accounts have stopped distributing and selling the recalled product(s) product(s)
  • verify that the recalled product(s) have been returned to the designated place(s) as stated in your Notice of Recall

It is the responsibility of the CFIA to follow up with some of your accounts to verify the effectiveness of the recall. Where it is determined that the recall was ineffective, your firm may be required to repeat the recall process.

Step 9: Control of the Recalled Product(s)

Your firm is responsible to ensure that recalled products do not re-enter the market.

  • separate and clearly identify recalled product(s)
  • reconcile quantities and monitor returned product(s)
  • record the recalled product(s) in your Recalled Product Records document

Step 10: Decide What to Do With the Returned Product

The action to be taken on the recalled product should be approved by the CFIA.

  • decide on the action to be taken on the recalled product e.g., correction, re-export, destruction
  • find out if the CFIA wants to witness/verify that the action has been taken
  • verify that the action has been effective
  • record the action taken for each product in your Recalled Product Records document

Step 11: Fix the Cause of the Recall

As the firm that imported the unsafe product, it is your responsibility for ensuring that all reasonable steps are taken to prevent similar recalls in the future.

  • put controls in place or revise existing controls to prevent similar problems in the future

Common Problems With Recalls, Potential Impacts And Recommended Solutions

Listed below are some common problems, potential impacts and recommended solutions associated with some of the steps in the Recall Procedures.

1. Press Release And Notice Of Recall

Problems:
  • the hazard is not clearly described
  • the urgency of the recall is not clearly stated
  • the key message is obscured by other information, e.g., advertising
  • instructions to consumers are not clear
Potential Impacts:
  • distributors, retailers and consumers may not understand the seriousness of the hazard
  • hazardous product may not be removed from sale or distribution in a timely manner
  • consumers may use the recalled product before they are aware of the hazard
  • the CFIA or the recalling firm may have to issue a second press release
Recommended Solutions:
  • state the hazard clearly e.g., Undeclared (Allergen) in (Product name)
  • put the word Urgent in the title of the notice
  • be brief and to the point, do not include promotional information
  • tell consumers what to do with the product e.g., destroy, return to the store for a refund

2. Preparation of the Distribution List

Problems:
  • the list is not provided to the CFIA within 24 hours after the firm is notified of the classification of the recall
  • key information in the distribution list is missing e.g. contact names, addresses, phone numbers
  • the list is not readable e.g., the print is too small or letters are not clear
  • the list includes customers who did not receive the recalled product(s)
Potential Impacts:
  • recalled product which has not been removed from sale is not identified in a timely manner
  • consumers may purchase and use the recalled product
  • verification of the effectiveness of the recall may be significantly delayed
Recommended Solutions:
  • develop the ability to identify customers who received specific codes of product quickly
  • develop the ability to prepare an accurate, complete distribution list within 24 hours

3. Informing the CFIA of a Recall

Problems:
  • CFIA is not notified of the recall
  • CFIA is notified days or weeks after the problem is identified by the importer
Potential Impacts:
  • hazardous product may not be removed from distribution and sale in a timely manner
  • consumers who purchased the product may use it before they are aware of the hazard
Recommended Solution:
  • notify the CFIA immediately if you suspect a product that your firm has manufactured and sold may pose a risk to the health of consumers

4. Identification of Product(s) To Be Recalled

Problems:
  • all of the sizes, lot codes, brands of affected product are not identified
  • other products affected by the recall are not identified
Potential Impacts:
  • hazardous product may not be removed from distribution and sale in a timely manner
  • consumers may use the recalled product before they are aware of the hazard
  • the CFIA or the recalling firm may have to issue a second press release
  • the firm may have to conduct a second recall
Recommended Solutions:
  • determine and include all of the product manufactured from the time the problem started to the time the problem was resolved
  • consider other products imported from the same manufacturing firm and produced on the same line or using a similar process

5. Notification of Customers

Problem:
  • the firm decides to remove the product from the retail level without informing customers of the recall
  • the notice of recall is not written, the firm has no record of what was said to customers
  • the notice of recall is mailed to customers
  • customers are not notified until days after the recall was classified
  • customers are not notified
Potential Impacts:
  • distributors, retailers and consumers may not be aware of the hazard
  • distributors, retailers and consumers may not understand the seriousness of the hazard
  • hazardous product may not be removed from sale or distribution in a timely manner
  • consumers may use the recalled product before they are aware of the hazard
  • the CFIA or the recalling firm may have to issue a second press release
Recommended Solution:
  • inform all customers of the recall immediately and in writing

6. Control of the Recalled Product

Problems:
  • recalled product is accidentally shipped to customers
  • recalled product is sold to consumers
Potential Impacts:
  • retailers may sell the recalled product
  • consumers may purchase and use the recalled product
Recommended Solutions:
  • segregate and clearly mark recalled product(s)
  • take precautions to ensure that the product is not accidentally released

7. Verifying the Effectiveness of the Recall

Problems:
  • the recalling firm does not verify that the notice of recall was received and action was taken
  • the recalling firm does not check to determine if the recall was effective
Potential Impact:
  • recalled product which has not been removed from sale is not identified in a timely manner
Solution:
  • implement the "Recall Effectiveness Procedures" described in Tab 2 of the guide

Appendix A: Press Release - Industry Template, Allergens

For Immediate Release

Allergy Alert - Undeclared (Name of Allergen) in (Name of Product)

(City), (Date) -- (Company Name), (Location) is warning consumers not to consume (Brand name and product name) imported from (Name of country) because it may contain (Name the allergen) which is not declared on the label.

The product being recalled is:
(Describe the product indcluding brand name, product name, packaging, size(s). Lot #, UPC code)

The product is distributed in (Name the provinces) or across Canada.

(Name the product) may cause a serious or life-threatening reaction in persons with allergies to (Name the allergen).

Consumers should (Tell consumers what to do with the recalled product e.g., return to point of sale for a refund).

There have been (Number) of reported illnesses associated with this product.

Consumers can contact (Company name) by calling (Phone number).

- 30 -

For more information, media please contact:

(Company contact name)
(Company name)
(City, province/state, country)
(Daytime phone)
(After-hours phone)

Appendix B: Notice of Recall - Template

Urgent - Recall of (Name of Product)

(Name and address of your company)
(Date)

Dear Customer,

or

Attention: (Name of customer contact)

(Your company name) is recalling the products listed below because they may contain (Name the problem, e.g. an ingredient which may cause an allergic reaction and is not declared on the label, bacteria, foreign pieces of material).

This table is a checklist of the recalled products listed below
Product NameBrandSizeCode, Best Before date, UPC

Please discontinue selling these products immediately by removing them from display, counting the amount in your inventory and storing them in a secure place.

Please contact all accounts to which you sell this product immediately and inform them of this recall.

(Your company name) staff will credit you for the recalled product. Please mark the product "recalled" and (Your company name) staff will call you to arrange pick up.

Important
Please record the time and date you received this Recall Notice and acknowledge receipt by signing and faxing this document to (Your company name) at (Your company fax number).

Date / Time Received:space Signature:space

Name of store / Distributor:space

Thank you for your cooperation.
(Signature)
(Your company's contact, their position, your company name)

4.0 General Reference Information On Recalls

Definitions

"Mandatory recall" means a recall as per Section 19 of the Canadian Food Inspection Agency Act.

19.(1) Where the Minister believes on reasonable grounds that a product regulated under an Act or provisions that the Agency enforces or administers by virtue of Section 11 poses a risk to public, animal or plant health, the Minister may, by notice served on any person selling, marketing or distributing the product, order that the product be recalled or sent to a place designated by the Minister."

"Product Withdrawal" means a firm's removal from further sale or use of a marketed product that does not violate legislation administered or enforced by the CFIA. It is not considered to be a recall.

"Public Warning" is a news release that pertains to a specific food recall. The title of this form of communication is "Warning/Mise en garde". The public warning is issued for those recalls requiring the recall of a product to the consumer level.

"Recall" (verb tense) means for a firm to remove from further sale or use, or to correct, a marketed product that contravenes legislation administered and/or enforced by CFIA.

"Recall" (noun tense) denotes the process of recalling the affected product and encompasses all tiers of the affected product distribution system.

"Recall Classification" means the numerical designation, i.e. Class I, Class II or Class III, assigned by the Office of Food Safety and Recall to a particular product recall to indicate the relative degree of health risk presented by the product being recalled.

"Recall Depth" means the level to which a recall is conducted (consumer, retail, distribution).

"Recalling firm" denotes a responsible firm which is accountable for the implementation of a recall.

"Stock Recovery" means a firm's removal or correction of a violative product that has not been marketed or that has not left the direct control of the firm. It is not considered to be a recall.

"Violative Product" is product that violates legislation administered or enforced by the Canadian Food Inspection Agency.

"Voluntary Recall" means a recall that is initiated and carried out by the recalling firm without ministerial order.

Recall Classifications

"Class I" is a situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death.

"Class II" is a situation in which the use of, or exposure to, a violative product may cause temporary adverse health consequences or where the probability of serious adverse health consequences is remote.

"Class III" is a situation in which the use of, or exposure to, a violative product is not likely to cause any adverse health consequences.

Date modified: