Page 9 - HFA Dateline 2022 Special Edition
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Alternatively, an FDA-mandated recall, also known       RECALL METHODS
        as a mandatory recall, occurs when FDA orders a
        manufacturer to recall a product or mandates recall     Voluntary Recall: Initiation of a Recall by a
        requirements. The FDA’s role is to oversee the          Manufacturer
        manufacturer’s recall strategy, monitor the recall for   Consistent with its responsibility to protect the public
        effectiveness and classify the recall.                  health from products that are defective or potentially
                                                                harmful, a manufacturer may voluntarily initiate a recall.
                                                                If a recall is manufacturer-initiated, the FDA reviews the
        RECALL CLASSIFICATION                                   information provided by the manufacturer, conducts a
                                                                health hazard evaluation, classifies the recall and then
        Class I: Includes a health hazard situation in which there   advises the manufacturer in writing of the assigned recall
        is reasonable probability that the use of the product will   classification. The FDA then places the notice of the recall
        lead to serious, adverse health consequences or death.   in the FDA Weekly Enforcement Report. Nearly all recalls
                                                                implemented in the U.S. are begun on a voluntary basis by
        Class II: Includes a potential health hazard situation in   the manufacturer.
        which use of, or exposure to, a violative product may
        cause temporary or medically reversible adverse health   If a manufacturer has voluntarily initiated a recall, it is the
        consequences or where the probability of serious adverse   manufacturer’s responsibility to promptly notify each of
        health consequences is remote.                          its direct accounts. If the recall extends beyond direct
                                                                accounts, then the direct accounts should be instructed
        Class III: Includes a situation in which use of or exposure   by the recalling manufacturer to contact sub-accounts
        to the product is not likely to cause adverse health    that may have received the product. Once all the
        consequences.                                           accounts have been informed about the recall, they must
                                                                promptly follow the recall strategy that was previously
        Market withdrawal: When a product has a minor violation
        that would not be subject to FDA legal action a “market   put in place for that account.
        withdrawal” occurs. The product is removed by the firm
        from the market or the firm corrects the violation.     FDA Requested Recall
                                                                In urgent situations, the FDA may request a recall. The
        Medical device safety alert: Released in circumstances in   request is directed to the manufacturer that has the primary
        which a medical device may present an unreasonable risk   responsibility for making or marketing the product. Class 1
        of substantial harm. These situations also are considered   category recalls are the most often requested recalls. It is
        recalls in certain cases.                               important to note FDA considers an FDA-requested recall to
                                                                be manufacturer initiated.
        Each FDA recall follows specific timelines and procedures
        depending upon the circumstances. For example, each     The associate commissioner for regulatory affairs approves
        recall is initiated with a written order that states the   all recall requests from FDA. A letter outlining the need for
        violation, the product, lot and serial numbers to be    a recall is sent to the manufacturer. After a recall has begun,
        recalled, and the timeline for the recall. Each recall is   the recall is entered in the Recall Enterprise System, which is
        unique and requires its own recall strategy developed by   a database used by the FDA to submit, update, classify and
        the Center Recall Unit (CRU). The CRU will consider how   terminate recalls.
        far the recall should extend; whether the public needs to
        be warned and, if so, in what geographical area; and the   FDA-Mandated Recalls
        appropriate assessment for recall effectiveness. A recall   The FDA’s authority to issue a mandatory recall is
        designated voluntary, requested and mandatory depends   very limited. Subjects of mandatory recalls can include
        on who initiates the process. Based upon the gravity of   devices, biological products, human tissue intended for
        the situation, the FDA will issue a public warning.
                                                                transplantation, infant formula, tobacco products and food.
                                                                The FDA also has discretion to order a mandatory recall if
                                                                it finds that a human cell, tissue or cellular or tissue-based
                                                                product is a source of dangerous infection to humans or does
                                                                not adequately protect against communicable disease.

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