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Abbott Told to Solve Contamination Problem

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Reuters

Abbott Laboratories Inc. must identify the source of contamination of its clot-busting drug Abbokinase before the Food and Drug Administration will consider releasing new lots for distribution. The FDA said Abbott has found Abbokinase contaminated with microorganisms, and the agency has uncovered information about manufacturing problems. Abbokinase is made with cultures of kidney cells from newborn babies who have died of natural causes. Since January, when the agency sent a letter to health professionals warning about potential risks, Abbott has reported six lots of Abbokinase contaminated with reovirus, which may cause minor respiratory or gastrointestinal problems or no symptoms at all. Another lot was contaminated with mycoplasma, which can cause respiratory and other infections. Abbott, based in Abbott Park, Ill., said none of the lots was distributed and that nearly all supplies of Abbokinase had been exhausted from pharmacists’ shelves. Abbott Labs shares closed up 6 cents at $41.94 on the NYSE.

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