FDA recall D-0035-2020

Shire Human Genetic Therapies, Inc. · Class I · drug

Product

Natpara (parathyroid hormone) for Injection, 25 mcg/dose, 2 pack cartridges, Rx only, For subcutaneous use only, Manufactured for: Shire-NPS Pharmaceuticals, Inc., Lexington, MA NDC 68875-0202-02

Reason for recall

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

Distribution

Product was distributed throughout the United States.

Key facts

Status: Terminated
Initiation date: 2019-09-12
Report date: 2019-10-02
Termination date: 2021-03-23
Voluntary/Mandated: Voluntary: Firm initiated
Location: Lexington, MA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0035-2020