
Press Office
Food and Drug Administration
U.S. Department of Health and Human Services
NOTE TO CORRESPONDENTS Lenore Gelb
November 15, 1996 (301) 443-3285
Consumer Hotline (800) 532-4440
MORE INFORMATION AVAILABLE FROM FDA
ON BLOOD AND PLASMA RECALLS
The FDA's Center for Biologics Evaluation and Research
(CBER) has established two new communication systems that offer
health providers and consumers immediate information about
recalls of therapeutic products derived from blood and plasma.
One is a new 24 hour toll-free number, 1-888-CBER-BPI, and
the other is an automated electronic mailing list. Both sources
offer current information about recalls and market withdrawals of
therapeutic products derived from blood, such as clotting factors
to treat hemophilia and immune globulins. If a product is taken
off the market because it is in violation of Federal law, it is
considered a recalled product. In some cases, manufacturers
withdraw products for other reasons, and these actions are
considered market withdrawals.
CBER has had other systems in place to provide this
information in the past, including a FAX Information System (1-
888-CBER-FAX), a consumer information line (1-800-835-4709) and a
link to FDA's home page on the World Wide Web
(http:\\www.fda.gov). The two new methods of notifying the
public will augment these existing services.
-More-
Page 2, NTC, Blood and Plasma Recalls
FDA is also sponsoring a public meeting on November 19,
1996, to explore issues related to notifying the public about
recalls of plasma-derived products. The meeting, organized in
conjunction with the National Heart, Lung, and Blood Institute of
the National Institutes of Health, and the Centers for Disease
Control and Prevention, will be held at the Masur Auditorium,
Bldg 10, 9000 Rockville Pike, Bethesda, Md. At the meeting,
attendees will learn about the ways the public health service
communicates information about recalls to the general public and
also discuss new ways to improve the current notification
methods.
Further details about the meeting and the new communication
systems are available from CBER at (301)827-1800, or from the
toll-free number 1-800-835-4709.
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