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November 6, 1996

Bacterial Sepsis Associated With Receipt of Albumin

JAMA. 1996;276(17):1373-1374. doi:10.1001/jama.1996.03540170017009

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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®-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[®]-25 and Albuminar[®]-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[®]