Page 9 - HFA Dateline 2022 Special Edition

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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