96-65 Lawrence Bachorik
October 3, 1996 (301) 443-1130
Recall of Albumin Expanded
A recently announced recall of one lot of human albumin, a
blood-derived product used to treat burn victims, patients
suffering from shock, and dialysis patients or others with low
blood pressure, has been expanded to include a total of 10 lots
of the product. The following may be used to answer questions:
On Sept. 23, 1996, Centeon L.L.C, King-of-Prussia, Pa.,
announced that it was recalling lot P61205 of its human albumin
product Albuminar-25 because the product had been linked to
reports of septicemia, a systemic blood infection, caused by the
bacterium Enterobacter cloacae. This recall covered
approximately 17,000 vials of the product, which is manufactured
in Centeon‘s Kankakee, Ill., facility.
Today, the Food and Drug Administration is confirming that
Centeon's recall is being expanded to include nine additional
lots of Albuminar 25% and 5%. The nine additional lots of
albumin being recalled, and their expiration dates, are as
follows:
Albumin 5%:
Lot P18607 (expiration June 26, 1999)
Lot L8212 (expiration December 20, 1996)
-More-
Page 2, Recall of Albumin Expanded
Albumin 25%:
Lot M60902 (expiration February 9, 1997)
Lot M54512 (expiration December 2, 1997)
Lot L58211 (expiration November 12, 1996)
Lot M61403 (expiration February 28, 1997)
Lot M63204 (expiration April 14, 1997)
Lot M54912 (expiration December 5, 1997)
Lot P61805 (expiration May 22, 1999)
These 10 lots of the product are being recalled because vials
containing the product may have been damaged during the
manufacturing process. Damaged vials may have become
contaminated.
Albumin is typically administered in hospitals, urgent care
centers, free-standing dialysis centers and other medical
facilities by a health professional. Individual patients are
unlikely to have this product in their possession.
Septicemia is a life-threatening condition. Patients
suffering from septicemia generally develop a high fever that
comes on rapidly, shaking chills and an abrupt drop in blood
pressure. The condition requires prompt medical attention.
Institutions possessing any of the recalled lots of albumin
should return them immediately to the manufacturer. The
company's Customer Support telephone number is 1-800-683-1288.
Health care professionals with questions may call the company's
Medical Information line at 1-800-504-5434.
FDA is asking health professionals to report any adverse
events associated with Albuminar to MedWatch, FDA's adverse event
reporting program, at 1-800-FDA-1088, and to the company.
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