Particulate issues cause Takeda US recall of Natpara

Japan’s largest drugmaker Takeda Pharmaceutical (TYO: 4502) is issuing a US recall for all doses of Natpara (parathyroid hormone) for Injection (25mcg, 50mcg, 75mcg, and 100mcg), with the news causing the company’s shares to dip 1.7% to 3,690 yen today.

Natpara, which came to Takeda via its recent $62 billion acquisition of Shire and generated global sales of $230 million in 2018, is indicated as an adjunct to calcium and vitamin D to control hypocalcemia in patients with hypoparathyroidism.

This recall is being conducted after discussions with the Food and Drug Administration and is effective immediately 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 Natpara solution. When the septum is repeatedly punctured, it is possible that small rubber fragments may detach into the cartridge.