D-0036-2020 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
13,897

Product Description

Natpara (parathyroid hormone) for Injection, 50 mcg, 2 pack medication cartridges, Rx only, For subcutaneous use only, Manufactured for: Shire-NPS Pharmaceuticals, Inc., Lexington, MA NDC 68875-0203-02

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

06628461, exp 8/31/2020 06661658, 07110136, 7164106, 07761970 exp 10/31/2020 07630717, 08689119, exp 12/31/2020 07769458, exp 4/30/2021 07983643, 08003758, exp 6/30/2021 08214790, exp 8/31/2020 NY17002DA, NY17002DB, exp 6/30/2020