Bayer Recalls 2 Unrefrigerated Lots of Antihemophilic Factor
Helixate FS vials in lot 372J033C and Kogenate FS vials in lot 372J009A that have not been continuously refrigerated are being recalled by Bayer Corp. because they may have less than the specified potency after nine weeks of storage at room temperature.
Bayer manufactures both recombinant antihemophilic factor products and distributes Kogenate FS; Aventis Behring distributes Helixate FS. The vials of Kogenate FS being recalled were distributed in Canada.
Although the companies had initially stated that the new formulation of recombinant antihemophilac factor, stabilized with sucrose not albumin, could be stored at room temperature not exceeding 25 degrees C for up to two months, they announced in late July that Helixate FS and Kogenate FS should be refrigerated at all times to maintain potency.