Hemophilia of North Carolina

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Notification - URGENT: Biologic Recall Information


March 11, 2020

Notification - URGENT Biologic Recall Information

Initiated by : Takeda
Event Id :  186
Event Date :  03-09-2020
Therapy
VONVENDITM
NDC Number Lot Number Size Packaging Expiration Date
0944-7553-02 TVA19005AA 1,300 iu - 05-09-2022
0944-7553-02 TVA19005AB 1,300 iu - 05-09-2022
Reason Takeda has requested pharmacies, distributors, wholesalers and hemophilia treatment centers exchange all unused doses of VONVENDI from these lots for replacement. These lots were thoroughly tested and met all requirements to be cleared for distribution to patients, meaning they passed standards for quality and safety.

Takeda received feedback from the FDA on how the company could improve its approach to manufacturing process testing. Based on this input, Takeda has decided to voluntarily retrieve any VONVENDI recalled lots at the pharmacy level, and provide patients the option of returning any unused product from the recalled lots for replacement.
Action Patients:
Although there is no requirement to return medicine because it is safe to use, patients have the opportunity to return doses from these lots if they are not comfortable taking them. If patients would like to replace product, they may contact Takeda's Hematology Support Center Team at 888-229-8379, Monday - Friday from 8:30am to 8:00pm Eastern Time.

Pharmacy:
Takeda is working directly with pharmacies, distributors and hemophilia treatment centers to replace product and is providing them recall mailings, including instructions to return product, if they received vials from these two lots of VONVENDI.
Other Information Takeda is conducting this recall with full transparency to the FDA. There is no impact to product availability, as sufficient VONVENDI supply from unaffected lots is available to meet patient needs.