Takeda Issues US Recall of Thyroid Drug Natpara Due to Particulates from CartridgeBy
Takeda Pharmaceutical has issued a US recall for all doses of Natpara (parathyroid hormone), a thyroid treatment, for injection (25 mcg, 50, mcg, 75 mcg, and 100 mcg) after discussions with the US Food and Drug Administration (FDA). This recall is effective immediately due to a potential issue related to rubber particulates originating from the rubber septum of the Natpara cartridge.
Takeda noted that 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.
Natpara is a parathyroid hormone indicated as an adjunct to calcium and vitamin D to control hypocalcemia in patients with hypoparathyroidism.
“Takeda is committed to supply integrity, and we are working closely with the FDA to resolve the issue and resume supply as soon as possible,” said the company in a September 5, 2019 statement. “The financial impact of the recall is currently being assessed in conjunction with the remediation plan. Takeda will share the financial impact once determined.”
Takeda says it is also working closely with regulatory agencies in relevant markets outside of the US where Natpara is available. The product continues to be available in these markets.