Notice: Takeda Recalls Natpara® (parathyroid hormone)
Date: 10/02/19
Attention Members and Providers: MHS wants you to know about a recent drug recall.
On September 16, 2019, the U.S. Food and Drug Administration (FDA) announced that Takeda was recalling all doses of Natpara® (parathyroid hormone) to the consumer level in the United States due to a potential issue related to rubber particulates originating from the rubber septum of the Natpara cartridge.
The FDA press release states the following:
Takeda is issuing a voluntarily recall for all doses of Natpara (parathyroid hormone) due to a potential issue related to rubber particulates originating from the rubber septum of the Natpara cartridge. Takeda initiated this recall because the rubber septum is punctured by a needle each day during the 14-day treatment period 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. Please immediately check your medical supplies, quarantine any drug products impacted and do not administer them. Takeda is recalling all doses of Natpara (parathyroid hormone) for Injection (25 mcg, 50 mcg, 75 mcg and 100 mcg). The NDC numbers associated with this recall include: 68875-0202-2, 68875-0203-2, 68875-0204-2 and 68875-0205-2. It is also vital to note that discontinuing Natpara abruptly can cause a sharp decrease in blood calcium levels which can result in serious health consequences. It is very important that patients contact their prescribing healthcare provider to discuss their individual treatment plan and ensure close supervision. This includes frequent monitoring of blood calcium levels and close titration of active vitamin D and calcium supplements upon stopping Natpara to avoid low blood calcium.
Providers can review the FDA’s full press release here.