Philippine Daily Inquirer 10:14 am | Sunday, May 11th, 2014
MANILA, Philippines—A pharmaceutical firm has voluntarily recalled from the market a drug used in organ transplants and the treatment of aplastic anemia.
In an advisory, 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.
“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,” the FDA said.
Covered by the recall order are Thymoglobuline batches C1272H08 with expiry date of March 2014, C1282H20 and C1282H31, with expiry dates of May 2014.
The drug was manufactured by Genzyme Polyclonals S.A.S in France. Tina G. Santos