Bayer initiates voluntary Kogenate recall due to mislabeling

23 July 2019

Germany’s Bayer (BAYN: DE) is voluntarily recalling two lots of Kogenate FS antihemophilic factor (recombinant) 2000 IU vials in the USA to the patient level. Certain vials from these two lots that were labeled as Kogenate FS actually contain the FVIII hemophilia A treatment, Jivi, antihemophilic factor (recombinant) PEGylated-aucl 3000 IU.

Despite the announcement, shares of Bayer were up 2.65% at 61.18 euros by early afternoon today.

The USA is the only country where affected products were distributed, and Bayer says it is working closely with the US Food and Drug Administration to manage the recall and to minimize disruption to supply and inconvenience to patients.

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