Product Recall Procedures

Recall is an effective method of removing or correcting violative products that may represent a health hazard to the consumer or user. It is an action taken by a manufacturer, distributor, or importer to carry out their responsibility to protect the public health and well-being.

During recalls, the primary role of the Health Protection Branch is to closely monitor the effectiveness of the firm's recall actions and to provide scientific, technical and operational advice. If a recalling firm's performance is deemed to be inadequate, the Branch is prepared to take appropriate action to remove the product from sale or use. A firm's recall does not preclude enforcement actions being taken by the Branch, as deemed appropriate, either during or following the completion of the recall.

Recall Notification

It is imperative that before or upon initiating a recall, the recalling firm notifies the Health Protection Branch. The basic information required includes the following:

1. The name of the recalled product and, where applicable, the identifying model designation, serial number, code, lot number and any other means of identification.
   

2. The total quantity of the recalled product originally in his possession.
   

3. The total quantity of the recalled product that had been distributed up to the time of the recall.
   

4. Area of the distribution of the recalled product by province and, if exported, by country.
   

5. The quantity of the recalled product still in his possession.
   

6. The reason for initiating the recall.

This information is usually provided verbally but it should be confirmed in writing. For drugs and medical devices, please refer to the specific recall notification requirements in the Food and Drug Regulations and the Medical Devices Regulations respectively.

Elements of a recall strategy

A recall strategy will address the following elements regarding the conduct of the recall:

1. Depth of recall - Depending on the product's degree of hazard and extent of distribution, the recall strategy will specify the level in the distribution chain to which the recall is to extend, as follows:
   

   1. Consumer or user level, which may vary with product, including any intermediate wholesale or retail level; or
      
      

   2. Retail level, including any intermediate wholesale level; or
      
      

   3. Wholesale level.
      
      

2. Recall Communications - From the recalling firm to its affected accounts. See Item 6, page 6.
   

3. Public Warning - The purpose of a public warning is to alert the public that a product being recalled presents a serious hazard to health. It is reserved for urgent situations (Class I and occasionally Class II Recalls) where other means for preventing use of the recalled product appear inadequate. The Assistant Deputy Minister decides whether a public recall announcement is mandatory and whether the Health Protection Branch will issue the warning.
   
   The recall strategy will specify the type of public warning, for example:

   1. General public warning through the general news media, either national or local as appropriate, or
      

   2. Public warning through specialized news media, e.g., professional, trade or ethnic press, or to specific segments of the population such as physicians, hospitals, etc.

4. Effectiveness checks - The purpose of effectiveness checks is to verify that all consignees at the recall depth specified by the strategy have received notification about the recall and have taken appropriate action. The method for contacting consignees may be accomplished by personal visits, telephone calls, letters, or a combination thereof. The recalling firm is responsible for conducting effectiveness checks. The firm's recall strategy will specify the method(s) to be used for and the level of effectiveness checks that will be conducted by the recalling firm as follows.

   1. Level A - 100 percent of the total number of consignees to be contacted;
      

   2. Level B - Some percentage of the total number of consignees to be contacted, which percentage is to be determined on a case-by-case basis, but is greater than 10 percent and less than 100 percent of the total number of consignees
      

   3. Level C - 10 percent or less of the total number of consignees to be contacted, which percentage is to be determined on a case-by-case basis; or
      

   4. Level D - No effectiveness checks.
      
      

   The Health Protection Branch, sometimes assisted by other health agencies, may carry out its own effectiveness checks as part of monitoring the recalling firm's performance. This is a separate exercise which must not be considered as part of, or supplement to, the recalling firm's responsibilities for adequate effectiveness checks.

Reference:

http://www.hc-sc.gc.ca/dhp-mps/compli-conform/recall-retrait/recall_proc-marche_retrait_e.html