China NMPA Product Recall - Recombinant human coagulation factor VIII for injection

Bayer Healthcare Co., Ltd. initiated a global voluntary recall of certain batches of its Recombinant Human Coagulation Factor VIII for Injection (Bayer Biotech) after routine stability studies revealed a decreasing potency trend. The manufacturer, Bayer HealthCare LLC (Berkeley, USA plant), identified an oxidation reaction between Factor VIII and trace hydrogen peroxide in the original solution as the likely cause. Although Bayer's assessment indicated no detected safety risks, the State Food and Drug Administration (SFDA), now known as NMPA, held discussions with the company regarding this issue, which was reported on August 1, 2016, and published on August 24, 2016. The SFDA mandated that Bayer conduct the recall in China concurrently with its global efforts, upholding its corporate responsibility for product quality. Affected product batches in China include 270T4J2 (2143 vials) and 270T222 (963 vials). The recall aligns with China's "Drug Recall Management Measures" and other pertinent regulations. Bayer has since identified the source of the hydrogen peroxide and implemented corrective measures to address the stability deviations. This proactive recall ensures adherence to product quality standards and regulatory compliance.