October 3, 2019
Takeda has issued a US recall for all doses of NATPARA® (parathyroid hormone) for Injection (25 mcg, 50 mcg, 75 mcg, and 100 mcg). The recall is effective immediately. This recall is being conducted after discussions with the US Food and Drug Administration (FDA) and is due to a potential issue related to rubber particulates originating from the rubber septum of the NATPARA cartridge. During the 14-day NATPARA treatment period, the septum is punctured by a needle each day to obtain the daily dosage of medicine solution. When the septum is repeatedly punctured, it is possible that small rubber fragments may detach into the cartridge.
Your patients will be notified through Takeda OnePath® patient services and asked to contact you for medical recommendations. Advise your patients of the risk of severe hypocalcemia when discontinuing NATPARA® and the importance of urgently contacting you if they experience sign or symptoms of hypocalcemia.
For questions, email provider.relationswest@premera.com.