Medication Monitor

Generic Name (Trade Name—Company)
September 26, 2019

Parathyroid hormone for injection

Recalled product may contain rubber particulates

Takeda is recalling all doses of parathyroid hormone (PH) for injection (25 mcg, 50 mcg, 75 mcg, and 100 mcg) because of a potential issue related to rubber particulates originating from the rubber septum of the cartridge. During the 14-day treatment period, the septum is punctured by a needle each day to obtain the daily dosage of PH solution. When the septum is repeatedly punctured, it is possible that small rubber fragments may detach into the cartridge.

Discontinuing PH abruptly can cause a sharp decrease in blood calcium levels, which can result in serious health consequences. It is critically important that patients contact their prescribing health care provider to discuss their individual treatment plan and ensure close supervision, including frequent monitoring of blood calcium levels and close titration of active vitamin D and calcium supplements upon stopping PH.

The product, a recombinant human protein with the full length 84–amino–acid sequence of endogenous PH, is currently approved in the United States as the only adjunctive treatment for adult patients with chronic hypoparathyroidism that cannot be adequately controlled with standard therapy alone (calcium and vitamin D).