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Further Response from Bayer on Kogenate® FS Recall

August 21, 2019
 CSL Recalls Single Lot of Mononine®

Hemophilia Federation of America and National Hemophilia Foundation continue to follow up on issues arising from Bayer’s distribution of mislabeled, expired clotting factor and subsequent recall of that product. The most recent set of joint NHF-HFA inquiries to Bayer focused on the short- and long-term medical consequences for affected patients. Bayer today released this response to the joint NHF-HFA letter.

We recognize that Bayer’s letter does not answer all the questions you may have arising from the product recall. NHF and HFA remind you to please reach out to your physician with any medical concerns..

We also remind you that Bayer has provided their call center number if you want to ask them questions, or if you have suffered financial losses due to the recall. That number is (888) 842-2937. You may also report adverse medical events directly to the U.S. Food and Drug Administration (www.fda.gov/medwatch, or 1-800-FDA-1088).

NHF’s and HFA’s inquiries into the Bayer recall and its ramifications continue. As always, NHF and HFA will keep the bleeding disorders community informed as we learn more.

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. Events like this one can cause a myriad of emotions. Please reach out to a social worker, provider, or trusted source of support.