Page 18 - HFA Dateline 2020-2021 Special Issue
P. 18
A Look at the
DRUG RECALL
PROCESS
BY HFA STAFF
It is important to pay manufacturer to recall a
attention when a product product or mandates recall
is recalled, but with all the requirements. The FDA’s role is
different sources of information and to oversee the manufacturer’s recall
the different types of recalls, it can be confusing. strategy, monitor the recall for effectiveness and
Recalls, designed to protect the public’s health, are classify the recall.
used as a way to deliver information to consumers in
an expeditious manner. RECALL CLASSIFICATION
A recall is an action taken by a manufacturer to Class I: Includes a health hazard situation in
remove a product (food, drugs, medical devices and which there is reasonable probability that the
cosmetics) from the market, initiated either by the use of the product will lead to serious, adverse
manufacturer or by request from the U.S. Food and health consequences or death.
Drug Administration. In either case, the manufacturer
removes or corrects a product that is in the market Class II: Includes a potential health hazard
and in violation of FDA rules and regulations. In both situation in which use of, or exposure to, a violative
cases, the FDA considers the recall to be manufacturer product may cause temporary or medically
initiated. reversible adverse health consequences or
where the probability of serious adverse health
Alternatively, an FDA-mandated recall, also known consequences is remote.
as a mandatory recall, occurs when FDA orders a
18 DATELINE FEDERATION < www.hemophiliafed.org
