Notice to Readers
Bacterial Sepsis Associated with Receipt of Albumin
The Food and Drug Administration (FDA) has designated as Class
I (defined by FDA as a strong likelihood that a product will cause
serious adverse health consequences or death) a recall of Centeon
Albumin, 25% (Human), U.S.P., Albuminar{Registered}-25
(manufactured by Centeon L.L.C., King of Prussia, Pennsylvania),
lot number P61205, because of Enterobacter cloacae sepsis
associated with receipt of product from this lot. Contamination of
the product may have been due to cracks in the vials during
manufacture. Cultures of unopened product grew Stenotrophomonas
multophilia and enterococci in addition to E. cloacae. Ten other
lots (P18607, L8212, M60902, M54512, L58211, M61403, M63204,
M54912, P61805, and P62906) of Centeon Albuminar{Registered}-25 and
Albuminar{Registered}-5 (albumin, 5% {human}, U.S.P.) also have
been recalled as a precaution because of the potential for
contamination due to similar manufacturing problems.
Hospitals, dialysis centers, and other users should
discontinue use of
these lots of Centeon Albuminar{Registered} and quarantine all
vials
belonging to these lots. Other lots should not be used if the vials
are
visibly cracked or the contents are visibly turbid. Health-care
professionals should report any episode of infection associated
with
Centeon Albuminar{Registered} to CDC's Hospital Infections Program,
National Center for Infectious Diseases (telephone {404} 639-6413;
fax
{404} 639-6459), and to FDA's MedWatch Program (telephone {800}
332-1088;
fax {800} 332-0178).
Centeon also is voluntarily recalling a single lot (P72304) of
Monoclate-P{Registered} Factor VIII used to treat hemophilia; no
adverse events have been reported in association with Monoclate-P
{Registered}. The investigation by FDA and Centeon is ongoing, and
additional information is available from FDA's Center for Biologics
Evaluation and Research, telephone (301) 827-2000 or (800)
835-4709.
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