By Fineline Cube The Food and Drug Administration (FDA) bureau of Taiwan, part of Greater China, has issued a recall order for two batches of GlaxoSmithKline’s (GSK, NYSE: GSK) asthma medication Nucala (mepolizumab) after hospital staff discovered glass fragments. The TFDA was promptly notified, leading to the recall action.
Impacted Lot Numbers and Recall Timeline
The recall affects lot numbers MX9M and S34T, with the process expected to be completed by August 7. The two batches in question include a total of 2,591 bottles. Given that the annual usage of Nucala in Taiwan is around 4,690 bottles, this recall represents a significant portion of the drug’s circulation in the country.
Nucala’s Indications and Market Presence in Taiwan
Nucala is approved in Taiwan for the treatment of severe refractory eosinophilic asthma in patients over the age of six and for adult patients suffering from eosinophilic granulomatosis with polyangiitis (EGPA), a rare form of vasculitis. There is no alternative treatment available for these patients, making the drug’s safety and availability critical. Nucala is also available in mainland China, where it was first approved in November 2021, indicating its importance across the region.-Fineline Info & Tech