D-0038-2020 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
8,003

Product Description

Natpara (parathyroid hormone) for Injection, 100 mcg, 2 pack medication cartridges, Rx only, For subcutaneous use only, Manufactured for: Shire-NPS Pharmaceuticals, Inc., Lexington, MA 68875-0205-02

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

06828752, exp 12/31/2019 07110118, exp 4/30/2021 07164107, exp 12/31/2019 07200436, 07301074, exp 4/30/2021 07482212, 07630715, exp 6/30/2021 07769460, exp 4/30/2021