Page 8 - HFA Dateline 2022 Special Edition
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A Look at the Drug
Recall Process
BY HFA STAFF
I A recall is an action taken by a manufacturer to remove
t’s important in the bleeding disorders community
to be aware of recalls and what a recall means. It is
a product (food, drugs, medical devices and cosmetics)
important to pay attention when a product is recalled,
but with all the different sources of information and from the market, initiated either by the manufacturer or
by request from the U.S. Food and Drug Administration
the different types of recalls, it can be confusing. (FDA). In either case, the manufacturer removes or
Recalls, designed to protect the public’s health, are corrects a product that is in the market and in violation
used as a way to deliver information to consumers in of FDA rules and regulations. In both cases, the FDA
an expeditious manner. considers the recall to be manufacturer initiated.
8 DATELINE FEDERATION < www.hemophiliafed.org