Page 10 - HFA_Dateline_2019_Q3_Fall

Understanding FDA
Drug Recall Procedures
It is important to pay attention when a product is recalled,
but with all the different sources of information, and
the different types of recalls, it can be confusing. Recalls,
designed to protect the public’s health, are used as a way to
deliver information to consumers in an expeditious manner.
A recall is an action taken by a manufacturer to remove a
product (food, drugs, medical devices and cosmetics) from
the market, initiated either by the manufacturer or by request
from the FDA. In either case, the manufacturer removes or
corrects a product that is in the market and in violation of
FDA rules and regulations. In both cases, the FDA considers
the recall to be manufacturer initiated.
Alternatively, an FDA-mandated recall, also known as a
mandatory recall, occurs when FDA orders a manufacturer
to recall a product or mandates recall requirements. The
FDA’s role is to oversee the manufacturer’s recall strategy,
monitor the recall for effectiveness and classify the recall.
Here are the different recall classifications.
X Class I: Includes a health hazard situation where there is
reasonable probability that the use of the product will lead If a manufacturer has voluntarily initiated a recall, it is
to serious, adverse health consequences or death.
X Class II: Includes a potential health hazard 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.
X C lass III: Includes a situation in which use of or exposure
to the product is not likely to cause adverse health
consequences.
X Market withdrawal: When a product has a minor violation
that would not be subject to FDA legal action a “market
withdrawal” occurs. The product is removed by the firm
from the market or corrects the violation.
The FDA’s role is to oversee the manufacturer’s recall strategy,
monitor the recall for effectiveness and classify the recall.
10 DATELINE FEDERATION < www.hemophiliafed.org
X Medical device safety alert: Released in circumstances
where a medical device may present an unreasonable risk
of substantial harm. These situations also are considered
recalls in certain cases.
A recall named voluntary, requested and mandatory depends
on who initiates the process. Based upon the gravity of the
situation, the FDA will issue a public warning.
Voluntary Recall:
Initiation of a Recall by a Manufacturer
Consistent with its responsibility to protect the public 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 information
provided by the manufacturer, conducts a health hazard
evaluation, classifies the recall, and then advises the
manufacturer in writing of the assigned recall classification.
The FDA then places the notice of the recall in the FDA Weekly
Enforcement Report. Nearly all recalls implemented in the
U.S. are begun on a voluntary basis by the manufacturer.
the manufacturer’s responsibility to promptly notify each
of its direct accounts. If the recall extends beyond direct
accounts, then the direct accounts should be instructed by
the recalling manufacturer to contact sub-accounts that
may have received the product. Once the all accounts have
been informed about the recall, they must promptly follow
the recall strategy that was previously put in place for that
account.
FDA Requested Recall
In urgent situations, the FDA may request a recall. The
request is directed to the manufacturer that has the primary
responsibility for making or marketing the product. Class
1 category recalls are most often requested recalls. It is
important to note the FDA considers an FDA requested recall
to be manufacturer initiated.