D-0037-2020 Class I Terminated

Recalled by Shire Human Genetic Therapies, Inc. — Lexington, MA

Recall Details

Product Type
Drugs
Report Date
October 2, 2019
Initiation Date
September 12, 2019
Termination Date
March 23, 2021
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
15,075

Product Description

Natpara (parathyroid hormone) for Injection, 75 mcg, 2 pack medication cartridges, Rx only, For subcutaneous use only, Manufactured for: Shire-NPS Pharmaceuticals, Inc., Lexington, MA NDC 68875-0204-02

Reason for Recall

Defective Delivery System: potential risk of rubber stopper particles clogging the needle and leading to underdosing

Distribution Pattern

Product was distributed throughout the United States.

Code Information

06628462, exp 5/31/2020 06651000, exp 9/30/2020 06661659, exp 6/30/2020 07110125, 07301073, exp 10/31/2020 07200435, 7/31/2020 07482211, exp 12/31/2020 07630714, exp 3/31/2021 NX170002DA, exp 12/31/2019 NX17004DA, exp 3/31/2020 NX17007DA, NX17007DB, NX17008DA exp 4/30/2020 NX17010DA, NX17012DA, exp 6/30/2020