Three batches of Transplant medicine recalled from PHL market

A pharmaceutical company has recalled three batches of thymoglobuline (rabbit-derived antibodies to treat rejection of transplanted organs) from the Philippine market. The drug being recalled is used in the treatment of severe aplastic anemia and organ transplants. Rabbit Anti-Human Thymocyte Immunoglobulin as a biological product indicated for immunosuppression in transplantation or prophylaxis and treatment of graft rejection.

The Food and Drug Administration (FDA) said Sanofi-Aventis Philippines Inc. has initiated a voluntary recall of three batches of Rabbit Anti-Human Thymocyte Immunoglobulin, or Thymoglobuline. The company has recalled batch C1272H08 with expiry date of March 2014 and batch C1282H20 and C1282H31, with expiry dates of May 2014.

FDA said that due to out of specification (OOS) findings on the product stability prior to the expiration date, specific batches of Rabbit Anti-Human Thymocyte Immunoglobulin (Thymoglobuline) 5mg/ml Powder for Solution for IV Infusion has been voluntarily recalled. According to FDA the recalled batches were manufactured in France.