Joint Statement #5 on Recall of Kogenate® FS Lots
Bayer announced the recall of two lots of Kogenate® FS antihemophilic factor (recombinant) 2000 I.U. vials on July 19, 2019. Bayer announced that 3000 I.U. of one product (Jivi), past its expiration date, had been mislabeled as another product (2000 I.U. of Kogenate FS) and distributed to the public for six months. This is a deeply troubling event that gives rise to questions, concern, and outrage within the community.
NHF and HFA previously submitted a letter to Bayer on July 26th focusing on the company’s plans for accomplishing the recall. You can read the NHF-HFA letter here and Bayer’s response here. You can also read a separate letter about the recall that Bayer sent out to healthcare providers (HCPs) here.
As part of our continuing communications with Bayer, today, NHF and HFA submitted another letter to the company to press for information about how this serious event happened, what the implications might be for patient health and care, and how Bayer will ensure similar errors do not happen again. NHF and HFA also have a scheduled meeting with the FDA to discuss this matter.
This is an ongoing discussion and NHF and HFA will keep the bleeding disorders community informed as information is gathered.
Please note that NHF and HFA do not recommend, endorse or make any representation about the efficacy, appropriateness or suitability of any specific products, treatments, or opinions. If you have any questions or concerns about your medical treatment, including your possible exposure to recalled product, please consult your physician.