Takeda Pharmaceutical Company Ltd. is recalling all doses of its thyroid drug Natpara in the U.S. due to potential contamination issues in the injection cartridge.
The medicine is used to treat hypoparathyroidism, a rare condition where the human body secretes abnormally low levels of parathyroid hormone, which plays an important role in regulating the body's calcium and phosphorus levels.
The Tokyo-based pharmaceutical company issued the recall after discussions with the U.S. Food and Administration due to potential issues related to rubber particulates from the rubber septum of the injection's cartridge.
The 14-day Natpara treatment period requires the septum to be punctured by a needle every day to acquire the medication and due to repeated puncturing, small rubber fragments can potentially detach and contaminate the cartridge.
Takeda is working closely with the U.S. regulator to resolve the issue and resume supply soon. The financial impact of the recall is currently being assessed, the company said.
