Recall Notice: Voluntary Recall Mononine Coagulation Factor IX (Human)

CSL Behring has announced a voluntary pharmacy level product recall of one batch of Mononine Coagulation Factor IX (Human), a plasma-derived product used to treat hemophilia B. CSL Behring’s notification states, Patients can continue to use product they may have. Although the potential for safety risk to patients is considered low, it cannot be fully excluded.”
The affected batch is identified as: P100125501
Patients who use this product are advised to check their medication for the lot number and call their pharmacy with questions regarding their prescriptions, or their healthcare provider regarding their treatment plan.
HFA and NHF recognize that recalls can be very unsettling for many in the bleeding disorders community. We are in communications with CSL Behring to obtain additional detailed and timely information regarding the events that led up to the recall, as well as CSL Behring’s plans for publicizing and accomplishing the recall. As has been our past practice (and consistent with the principles articulated at the January 2020 Safety Summit), HFA and NHF commit to keeping the bleeding disorders community informed as we gather further information. Community Members who wish to express safety-related concerns with the national organizations are encouraged to submit feedback here.
For the full text of CSL Behring’s announcement, click here.
For an explanation of the FDA’s product recall procedures and classifications, click here.
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 use of the product at issue, please consult your physician.