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MILES WITHDRAWING PROLASTIN LOTS FOR GENETIC EMPHYSEMA

Executive Summary

MILES WITHDRAWING PROLASTIN LOTS FOR GENETIC EMPHYSEMA because 20 of the lots of the orphan product human alpha-l-proteinase inhibitor were manufactured with intermediates purchased from the American Red Cross. The withdrawal was initiated, FDA said in a Nov. 17 "Talk Paper," "because a frequent ARC blood donor has been diagnosed" post-mortem "with Creutzfeldt-Jakob Disease (CJD), a rare neurological disorder."
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PS025326

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