Class I Recall Issued for Prescription Hormone

A defective delivery system has prompted a Class I recall of 25-mcg, 50-mcg, 75-mcg, and 100-mcg doses of Natpara (parathyroid hormone) for injection. According to the October 2, 2019, US Food and Drug Administration (FDA) Enforcement Report, there is a risk of rubber stopper particles clogging the needle and causing underdosing. 

“As of the date of this recall, Takeda is not aware of any adverse events directly related to matter,” the company wrote in a letter announcing the recall. “After discussions with the US FDA, the company is issuing this recall as a precaution.” 

Shire Human Genetic Therapies, Inc., a Takeda company, voluntarily initiated the recall September 12, 2019. On October 1, 2019, the FDA gave the recall a Class I designation, which warns use of the affected product could cause serious adverse health consequences or death. 

The recall includes the following Natpara products: 

• Natpara injection, 25 mcg, 2-pack cartridges (NDC 68875-0202-02) from lots 08569357 (Exp. 4/30/20), 07983652 (Exp. 6/30/21), and 08544833 (Exp. 6/30/21);
• Natpara injection, 50 mcg, 2-pack cartridges (NDC 68875-0203-02) from lots 06628461 (Exp. 8/31/20), 06661658, 07110136, 7164106, and 07761970 (Exp. 10/31/20), 07630717 and 08689119 (Exp. 12/31/20), 07769458 (Exp. 4/30/21), 07983643 and 08003758 (Exp. 6/30/21), 08214790 (Exp. 8/31/20), and NY17002DA and NY17002DB (Exp. 6/30/20); 
• Natpara injection, 75 mcg, 2-pack cartridges (NDC 68875-0204-02) from lots 06628462 (Exp. 5/31/20), 06651000 (Exp. 9/30/20), 06661659 (Exp. 6/30/20), 07110125 and 07301073 (Exp. 10/31/20), 07200435 (7/31/20), 07482211 (Exp. 12/31/20), 07630714 (Exp. 3/31/21), NX170002DA (Exp. 12/31/19), NX17004DA (Exp. 3/31/20), NX17007DA, NX17007DB, and NX17008DA (Exp. 4/30/20), and NX17010DA and NX17012DA (Exp. 6/30/20); and 
• Natpara injection, 100 mcg, 2-pack cartridges from lots 06828752 (Exp. 12/31/19), 07110118 (Exp. 4/30/21), 07164107 (Exp. 12/31/19), 07200436 and 07301074 (Exp. 4/30/21), 07482212 and 07630715 (Exp. 6/30/21), and 07769460 (Exp. 4/30/21). 

Products affected by the recall were distributed throughout the United States. 

Natpara is a prescription parathyroid hormone used with calcium and vitamin D to control hypocalcemia in people with hypoparathyroidism. 

—Jolynn Tumolo