07 Sep 2012, BioSpectrum Bureau , BioSpectrum
Singapore: Sanofi-aventis Taiwan has recalled one lot of Thymoglobulin (Antithymocyte immunoglobulin of rabbit origin), indicated for prevention and cure of rejection of grafts (in cases such as kidney transplantation, heart transplantation and bone marrow transplant) and serious aplastic anemia, as a preventive measure. The company has reported this decision to recall the lot to the Taiwanese Food and Drug Administration (FDA).
The Taiwan FDA website said although the product met the quality standard, they decided to implement strict quality control and proactively conduct a preventive recall. The FDA had asked the company to recall the product as soon as possible and contacted the relevant medical institutions through the emergency contact network to ask the hospitals and clinics to recall the product.
The website said the result of the stability test of another lot of the product (which was not imported to Taiwan) did not meet the requirement of the originally approved standard following which the recall decision was taken as a preventive measure.