Late yesterday (February 25, 2020), Takeda announced a pharmacy-level recall of two lots of VONVENDI von Willebrand factor (recombinant) 1,300 IU vials. Takeda’s announcement stated that
“Although both lots met all acceptance criteria, Takeda is issuing a voluntary recall out of an abundance of caution. Takeda believes that despite this voluntary recall that [sic] there is no impact to the sterility, quality, safety and potency of the two lots of VONVENDI in scope of the recall.”
HFA and NHF recognize that recalls can be very unsettling for many in the bleeding disorders community. We are in communications with Takeda to obtain additional detailed and timely information regarding the events that led up to the recall, as well as Takeda’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.
For the full text of Takeda’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.