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Recall Observatory FDA recall evidence

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

D-0035-2020

September 12, 2019

Class I

Product summary

Firm
Shire Human Genetic Therapies, Inc.
Event
Event 83792
Status
Terminated
Classification
Class I
Quantity
1,556
Official record key
drug-enforcement:D-0035-2020

Official wording

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

Code information: 08569357, exp 4/30/2020; 07983652, 08544833, exp 6/30/2021

Distribution pattern: Product was distributed throughout the United States.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

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