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Recall Observatory FDA recall evidence

Drug product

Natpara (parathyroid hormone) for Injection, 75 mcg, 2 pack medication cartridges, Rx only, For subcutaneous use only, Manufactured for: Shire-NPS Pharmaceuticals, Inc., Lexington, MA NDC 68875-0204-02

D-0037-2020

September 12, 2019

Class I

Product summary

Firm
Shire Human Genetic Therapies, Inc.
Event
Event 83792
Status
Terminated
Classification
Class I
Quantity
15,075
Official record key
drug-enforcement:D-0037-2020

Official wording

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

Code information: 06628462, exp 5/31/2020 06651000, exp 9/30/2020 06661659, exp 6/30/2020 07110125, 07301073, exp 10/31/2020 07200435, 7/31/2020 07482211, exp 12/31/2020 07630714, exp 3/31/2021 NX170002DA, exp 12/31/2019 NX17004DA, exp 3/31/2020 NX17007DA, NX17007DB, NX17008DA exp 4/30/2020 NX17010DA, NX17012DA, 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