Baxter Healthcare Corporation has sent a notice of a labeling error affecting the expiration date of the Sterile Water for Injection that is packaged as a diluent with Recombinate [Antihemophilic Factor (Recombinant)].
Baxter BioScience has announced that it is voluntarily recalling one lot of Recombinate Antihemophilic Factor (Recombinant). Baxter states that this recall is being taken as a precautionary measure after a retrospective review of its manufacturing process revealed a breach in aseptic processing.
The FDA and Triad Group, Inc., a manufacturer of over-the-counter alcohol swabs, have recalled lots of alcohol prep pads, alcohol swabs, and alcohol swabsticks that have private labels but are all manufactured by Triad Group, Inc.
The FDA has recalled Exel/Exelint Huber needles, Exel/Exelint Huber Infusion Sets and Exel/Exelint “Securetouch+” Safety Huber Infusion Sets manufactured by Nipro Medical Corporation for Exelint International Corporation.
Health authorities in the United Kingdom have announced that a man with hemophilia A who died of unrelated causes was found at post-mortem examination to have evidence of infection with the agent causing variant Creutzfeldt-Jakob disease (vCJD), the human form of “mad cow disease.”
CSL Behring L.L.C. is initiating a field correction of component packs packaged with five specific lots of Mononine®. The packs do not have a complete seal between the soft blister pack and the package cover.
On Monday, November 27th, the Food and Drug Administration (FDA) released documents relating to the Agency’s assessment of the risk of acquiring variant Creutzfeld-Jakob Disease (vCJD), a human form of mad cow disease, for persons with bleeding disorders who have used US licensed plasma-derived factor VIII products (pdFVIII).