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Recall Observatory FDA recall evidence

Drug product

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

D-0036-2020

September 12, 2019

Class I

Product summary

Firm
Shire Human Genetic Therapies, Inc.
Event
Event 83792
Status
Terminated
Classification
Class I
Quantity
13,897
Official record key
drug-enforcement:D-0036-2020

Official wording

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

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

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