Notice to Readers
Voluntary Worldwide Recall of Albuminar{Registered} and
Plasma-Plex{Registered} by Centeon, L.L.C.
On October 9, 1996, Centeon, L.L.C. (King of Prussia,
Pennsylvania) announced a worldwide recall of all lots of Albumin,
5%, 20%, 25% (Human), U.S.P. (Albuminar{Registered}-5,
Albuminar{Registered}-20, Albuminar{Registered}-25), and Plasma
Protein Fraction, (Human) U.S.P. 5% Solution Heated-Treated
(Plasma-Plex{Registered}, PPF) distributed under the Centeon or
Armour label as a precaution because of concerns related to
manufacturing (1). Hospitals, dialysis centers, and other users
should discontinue use of all lots of Centeon/Armour
Albuminar{Registered} and Plasma-Plex{Registered}, quarantine all
vials, and contact their distributors or Centeon for disposition
orders.
Health-care professionals should report any episode of
infection associated with Centeon Albuminar{Registered} or
Plasma-Plex{Registered} to CDC's Hospital Infections Program,
National Center for Infectious Diseases (telephone {404} 639-6413};
fax {404} 639-6459), and to Food and Drug Administration's (FDA's)
MedWatch Program (telephone {800} 332-1088; fax {800} 332-0178).
Replacement albumin is available from other U.S.-licensed
sources. Shortages should be reported to the FDA Biologics Supply
Officer, telephone (301) 827-0379.
Reference
CDC. Bacterial sepsis associated with receipt of albumin. MMWR
1996;45:866-7.
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