Sanofi's Genzyme recalls transplant drug after stability test failure
The company, whose vaccine division has been battling mold problems at a plant in Canada, now is voluntarily recalling 9 lots of Thymoglobulin, used to treat kidney transplant rejection. The company recalled one lot Aug. 2 after it failed a stability test, Reuters reports. Genzyme thinks the test failure might stem from a problem with an ingredient, and so has extended the recall to another 8 lots that used the same ingredient.
"Genzyme has not identified any new safety risk to patients who have received Thymoglobulin from the implicated lot numbers, and there are no confirmed safety issues directly associated with the stability failure," the FDA said in a recall notice on its website, Reuters reports.
The plant where the drug was produced was not identified but in 2007, the FDA sent a warning letter to a Sanofi plant in Lyon, France, which made Thymoglobulin.
Sanofi Pasteur, the largest operation devoted to human vaccines in the world, in June recalled four batches of the tuberculosis vaccine BCG and suspended production at a plant in Canada after regulators found problems with sterility. The result will be shortage in some countries. There were also worries that the halt in production could lead to a global shortage of the bladder cancer drug ImmuCyst.
An FDA warning letter letter posted in July laid out two dozen observations at the Sanofi Pasteur plant, zeroing in on mold and contamination problems that led the company to close some operations.
- here's the Reuters story
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