|James P. Ellison and Anne K. Walsh’s FDA Deskbook: A Compliance and Enforcement Guide provides an in-depth discussion on recalls.
A firm conducting a recall must develop a recall strategy taking into account the results of the Health Hazard Evaluation (HHE), ease in identifying the product, the degree to which the product’s deficiency is obvious to the consumer or user, the degree to which the product remains unused in the marketplace, and the continued availability of essential products. FDA will review and approve the recall strategy of a recalling firm. The elements of a recall strategy are:
- Depth of Recall The depth of recall pertains to the level in the distribution chain to which the recall will be extended. This will depend on the product’s degree of hazard and extent of its distribution. For example, the recall could extend all the way to the consumer or user level, it could stop at the retail level, or it may not need to go beyond the wholesale level.
- Public Warning A public warning is intended to alert the public that “a product being recalled presents a serious hazard to health.” It is only used in urgent situations for which other means of preventing use of the product appear inadequate. FDA will usually issue the warning in consultation with the recalling firm. If the firm issues its own warning, it should submit the warning to FDA for review and comment prior to distribution, along with a plan for distribution. The recall strategy should indicate whether a public warning is needed and how it will be issued, for example, via general or specialized news media.
- Effectiveness Checks Effectiveness checks are required to confirm that all consignees at the specified recall depth received the notification. Consignees may be contacted by whatever means deemed appropriate by the recalling firm, including by letter, telephone calls, or a combination. It is recommended that a firm conduct at least the initial effectiveness check in writing, and may then follow up via telephone if no response is received. When a phone call is made, the firm should document the call and that documentation should be retained in the recall record. The recall strategy will specify the methods to be used and the level of effectiveness checks that will be conducted. Depending on the product involved and the health hazard presented by the product, a firm may be required to contact 100% of consignees, or may not be required to conduct an effectiveness check at all.
TO LEARN MORE ABOUT THE FDA, READ:
FDA Deskbook: A Compliance and Enforcement Guide Edited by James P. Ellison and Anne K. Walsh (Hyman, Phelps & McNamara, P.C.)