Bayer Kogenate FS recall

Bayer initiates recall of Kogenate FS and Aventis' Helixate FS after failure to meet potency specifications after nine weeks at room temperature. The recall, initiated Jan. 9, involves 10,000 vials. Bayer issued a similar recall in July 2000. Shipments of Kogenate FS were halted in March 2001 after FDA cited GMP violations (1"The Pink Sheet" March 26, 2001, p. 15)...

Bayer initiates recall of Kogenate FS and Aventis' Helixate FS after failure to meet potency specifications after nine weeks at room temperature. The recall, initiated Jan. 9, involves 10,000 vials. Bayer issued a similar recall in July 2000. Shipments of Kogenate FS were halted in March 2001 after FDA cited GMP violations (¹ , p. 15)....