PlainRecalls
FDA Drug Critical Class I Terminated

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

Reported: October 2, 2019 Initiated: September 12, 2019 #D-0036-2020

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

Details

Units Affected
13,897
Distribution
Product was distributed throughout the United States.
Location
Lexington, MA

Frequently Asked Questions

What product was recalled?
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. Recalled by Shire Human Genetic Therapies, Inc.. Units affected: 13,897.
Why was this product recalled?
Defective Delivery System: potential risk of rubber stopper particles clogging the needle and leading to underdosing
Which agency issued this recall?
This recall was issued by the FDA Drug on October 2, 2019. Severity: Critical. Recall number: D-0036-2020.