Page 8 - HFA Dateline 2019-2020 Special Issue

A Look at the

Drug Recall Process

is important to pay attention when a product is recalled, but with all the different sources
It 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.
Y Class I: Includes a health hazard situation in which there is reasonable probability
that the use of the product will lead to serious, adverse health consequences or death.
Y 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.
Y Class III: Includes a situation in which use of or exposure to the product is not likely
to cause adverse health consequences.
Y 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 the firm corrects the violation.
Y Medical device safety alert: Released in circumstances in which a medical device
may present an unreasonable risk of substantial harm. These situations also are
considered recalls in certain cases.
A recall designated 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

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