Talecris Biotherapeutics recently reported two “Important Drug Information” notifications to the
U.S. Food and Drug Administration (FDA) concerning four lots of Koate DVI®, its plasma-
derived factor VIII product. The notifications, which were sent on July 24, 2006, identified
printing errors on certain product cartons of Koate DVI®.
The errors, which only appeared on the product cartons, involved the amounts listed for certain
product contents. The specific error on the cartons for lot number 26N7802 involved a
typesetting mistake that omitted the 'µ' symbol. The labels on the cartons for lot numbers
26N6XW1, 26N6N01, 26N7H01 incorrectly state that the product contains not more than 10
µg/mL aluminum when it actually consists of not more than 1 µg/mL aluminum.
Talecris has stated that all package inserts contain accurate information. To date, it has not
received any complaints for these lots. According to Talecris, the product is suitable for
Koate DVI® is indicated for the treatment of bleeding episodes in patients with hemophilia A.
Read the FDA notification for Lot Number 26N7802>>
Read the FDA notification for Lot Numbers 26N6XW1, 26N6N01, 26N7H01>>
Source: FDA Center for Biologics Evaluation and Research notification dated July 24, 2006