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FDAnews Drug Daily Bulletin
Oct. 5, 2012 | Vol. 9 No. 196
Stability Concerns Prompt Recall of Genzyme’s Kidney Transplant Drug
Genzyme is voluntarily recalling nine lots of its kidney transplant drug Thymoglobulin after one product lot failed a periodic stability test, the Sanofi subsidiary says. The additional lots of the antibody were pulled because they were made with raw materials of comparable quality to the lot that was flagged, Genzyme explained. Those materials, determined to be the root cause of the stability failure, could potentially weaken the drug before it expires, the drugmaker noted.
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