Food Product Recalls Guidance For Industry
Table of Contents
Introduction
Abbreviations
Recall Terminology
Recall Classifications
Public Notification and the Press Release
Example Press Releases
Recommended Wording for Specific Contaminants
Example Customer Notification Letter
Example of In-Store Notification
Regulators’ Roles and Authority
Contacts and Additional Resources
Recall Terminology
Recall – A firm’s voluntary removal of distributed food products from commerce when there is reason to believe that such products are adulterated or misbranded under the provisions of applicable state and federal laws. “Recall” does not include a market withdrawal or a stock recovery.
Market Withdrawal – A firm’s removal or correction by its own volition of a distributed product that involves a minor infraction that would not warrant legal action by MDA, or involves no violation of the state or federal laws, or health hazard.
Stock Recovery – A firm’s removal or correction of product that has not been marketed or has not left the direct control of the firm. For example, product is located on premises owned by or under the control of the firm and no portion of the lot has been released for sale or use.
Recall Classifications – MDA assesses the public health concern or hazard presented by a product being recalled, or considered for recall, whether firm initiated or requested by MDA, and classifies the concern using criteria developed by the FDA:
Class I – A situation in which there is a strong likelihood that the use of, or exposure to, a violative product will cause serious adverse health consequences or death.
Class II – A situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
Class III – A situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
Depth of Recall – The level of product distribution to which the recall is to extend:
Consumer level – This includes household consumers as well as all other levels of distribution.
Retail level – This includes all retail sales of the recalled product.
User level – This includes hotels, restaurants, and other food service institutional consignees.
Wholesale level – This is the distribution level between the manufacturer and the retailer. This level may not be encountered in every recall situation (e.g., the recalling firm may sell directly to the retail or consumer level).
Scope – This defines the amount and kind of product in question. For example, all products produced under a single HACCP plan between performance of complete cleaning and sanitation procedures (clean up to clean up).
Disposition – The firm’s action to correct a situation leading to the recall such as relabeling, reworking, or destroying product.
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