On January 26, Takeda, in agreement with the US Food and Drug Administration (FDA), has decided to conduct a voluntary market withdrawal for two product lots of 650 IU VONVENDI [von Willebrand Factor (recombinant)] in the US with immediate effect.
This withdrawal is being conducted out of an abundance of caution due to misprinted product labels with the incorrect expiration date. The impacted lots of VONVENDI are Item Code 1504819, lots TV A22004AA and TV A22004AB.
There is no quality issue with VONVENDI. The safety and efficacy profile of VONVENDI remains consistent with the product Prescribing Information. The expiration date printed on the labled on the outside of the VONVENDI package (June 27, 2025) is six months after the actual expiration date (January 27, 2025)/
We put patients at the forefront of all that we do. Therefore, we are withdrawing any impacted VONVENDI from specialty pharmacies and distributors one year ahead of the expiration date to help ensure that patients can continue to administer VONVENDI as prescribed by their health care provider. No other Takeda therapies are impacted in the US.
Market Withdrawal Instructions:
The impacted lots of VONVENDI are listed below:
Product Lot Number
650 IU VONVENDI TV A22004AA
650 IU VONVENDI TV A22004AB
If you have further questions, please contact your pharmacy provider or prescribing health care provider directly.