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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

  1. CDC. Bacterial sepsis associated with receipt of albumin. MMWR 1996;45:866-7.





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