Increase Integrity of Single-use Assemblies Immediately Before Use.
ATMI Life Science
A US FDA investigation of two deaths and a case of intercranial bleeding at the Beebe Medical Center in Lewes, Delaware has found no link to a batch of the blood thinner heparin made by Baxter International.
Camille Farhat, general manager of Baxter Pharmaceuticals & Technologies said that: “Following extensive product testing and further medical evaluation, we are confident that the events at Beebe Medical Center are unfortunate, isolated, institution-specific issues, unrelated to the quality of Baxter’s heparin premix product.”
The Food and Drug Administration (FDA) began its examination on May 11 after it emerged that all three patients had been treated with the drug, the active pharmaceutical ingredient (API) for which was supplied by Pfizer.
