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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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