Companies Change Storage Condition for Antihemophilic Factor
The change in storage condition to refrigeration at all times was made to ensure that the products maintain at least 80 percent of their labeled potency through the expiration date. All new packages of Kogenate and Helixate will include labeling indicating that the products should be stored at 28 degrees C.
Aventis also recently initiated a recall of Mononine lot X29601 (expiration date of Jan. 11, 2003), containing factor IX, because samples of the lot were found to have less than 80 percent of the labeled potency.
Bayer manufactures Helixate products for Aventis.