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Class I Recall Issued for Prescription Hormone
“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