Medical Advisory

In a significant development within the gene editing arena, Intellia Therapeutics has announced its decision to opt out of a hemophilia B program, relinquishing control of CRISPR/Cas9-based gene editing work on factor IX treatments to its partner, Regeneron.

Takeda notifies the U.S. Food and Drug Administration (FDA) of reports of plastic particles originating near the luer port of the BAXJECT II device.

Advisory #428 notes these medications are administered in a hospital setting only by trained healthcare professionals.

Ferring has extended the recall of Stimate to the consumer level.

CSL Behring and Ferring Pharmaceuticals have announced a recall of lots of Stimate®.

Bayer has announced a recall of two lots of Kogenate® FS 2000 IU vials.

Grifols Announces Recall of One Lot of Profilnine. This recall is being conducted as a precautionary measure.

CSL Behring Discontinues Production and Distribution of Monoclate-P®

Bayer  announces voluntary recall on additional lots of Kogenate FS Antihemophilic Factor (Recombinant).

CSL Behring extends voluntary recall of two lots of Helixate FS with vial adapter .

Bayer announces a recall of 2 lots of Kogenate FS due to loss of potency.

CSL Behring has announced a recall of 2 lots of Helixate FS due to loss of potency.

Kedrion Biopharma is placing a voluntary, temporary hold on future shipments of Koate DVI.

NHF’s Medical and Scientific Advisory Council (MASAC) has assessed three recent publications suggesting elevated inhibitor rates in a specific product.

Covidien, a healthcare products company, initiated a voluntary recall of certain lots of MonojectTM prefill flush syringes due to the syringes being filled with water that had not been subjected to their autoclave sterilization process.

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)].

In January 2011, NHF issued a Medical Advisory (#412) about a recall of nonsterile alcohol wipes produced by one company, Triad Group, Inc.

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 Food and Drug Administration has issued a notice that there is currently a shortage of Desmopressin Acetate (DDAVP), Intravenous Formulation, due to increased demand and manufacturing delays.

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.

CSL Behring L.L.C. has decided to initiate a voluntary recall of four lots of Monoclate-P, 1000 Unit. Vials from these four lots were distributed beginning on August 4, 2008.

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).

The National Hemophilia Foundation has been notified of an alert issued by Novo Nordisk regarding a shipment of NovoSeven Coagulation Factor VIIa (Recombinant) that is missing from a storage facility. 

The Food and Drug Administration has issued a nationwide alert against the use of all lots of preloaded syringes containing either heparin or sodium chloride intravenous catheter flushes manufactured by IV Flush, LLC because new cases of infection associated with use of these possibly contaminated products have been reported.

The National Hemophilia Foundation (NHF) has been notified by ZLB Behring that a single lot of hemophilia clotting factor manufactured in 1996 by its predecessor company, Centeon, has been linked to a French donor who later developed variant Creutzfeldt-Jakob Disease (vCJD).

The National Hemophilia Foundation has been contacted by several hemophilia treatment centers (HTC) regarding a "beige substance" on the tip of butterfly needles distributed by a former Abbott division now an independent company called Hospira. 

On September 21, 2004, United Kingdom (UK) health authorities informed people with hemophilia and other bleeding disorders that they are considered "at risk" for variant Creutzfeldt-Jakob Disease (vCJD) if they used UK plasma products manufactured between 1980 and 1998. These products were made from plasma collected from donors in the UK who were later identified to have vCJD or possibly from donors who still remain asymptomatic for vCJD.