NYS Bleeding Disorders Coalition Issues Statement Regarding Kogenate Recall

August 8, 2019

Clinical News

STATEMENT REGARDING THE RECENT RECALL OF KOGENATE FS

ANTI-HEMOPHILIC/BLOOD CLOTTING FACTOR BY BAYER PHARMACEUTICAL

UNYBDC


The New York State Bleeding Disorders Coalition is extremely concerned at the recent recall by Bayer Pharmaceutical of Kogenate FS. NYSBDC fully supports the joint statement by the National Hemophilia Foundation and Hemophilia Foundation of America that “the fact one product (Jivi), past its expiration date, was mislabeled as another product (Kogenate FS) and distributed to the public for six months is an event that never should have happened.”

Furthermore, NYSBDC fully supports the efforts by NHF/HFA to ensure that every patient affected by this recall is properly notified and to obtain answers from Bayer on how the situation occurred and what steps Bayer will take to prevent this or any similar situation from occurring in future. We expect Bayer to cooperate fully with the NHF/HFA in all these efforts and to cooperate fully with the US Food & Drug Administration on any inquiry into the matter.

NYSBDC considers the safety and reliability of the blood clotting factor supply of the utmost priority. Patients depend on clotting factor for their health; anything that may compromise product safety or call into question the reliability of the product supply chain is an extremely serious matter and must be dealt with expeditiously, transparently, and with the utmost care.

Patients, families, clinicians, and providers have a right to know that clotting factor products are safe and that only correctly labelled, unexpired clotting factor is being provided. We look forward to Bayer doing everything possible to restore confidence to our community and ensure safety and quality.

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