Malecare received more detail from Ms. Gissoo Decotis, Deputy Director of Oncology Advocacy Relations Bayer HealthCare, LLC. The following is about Bayer’s efforts to insure safety and get Xofigo back into the market.
“Following extensive root cause analyses, corrective actions at the manufacturing site were put into place. These actions included isolation of the affected batches, comprehensive maintenance and cleaning activities, inspection of stoppers and packaging materials, as well as implementation of a temporary release procedure including a modified visual inspection process. In addition to the measures taken at the production facility, Bayer is also implementing a filtration process at Cardinal Health (where the patient ready doses are prepared for use in the clinics.”
We’re encouraged by Bayer’s renewed commitment to keeping patients informed.