FDA Recall D-0037-2020

Shire Human Genetic Therapies, Inc. · Lexington, MA

Class I — life-threatening Terminated 558 days on record

Highest impact — Class I recall — FDA determination of strong likelihood of serious adverse health consequence or death.

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

Lot / code: 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

Quantity: 15,075

Reason for recall

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

Recall record

Recall number: D-0037-2020
Classification: Class I
Status: Terminated
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: Letter
Distribution: Product was distributed throughout the United States.
Recall initiated: 2019-09-12
Classified by FDA Center: 2019-10-01
FDA published: 2019-10-02
Terminated: 2021-03-23
Recalling firm: Shire Human Genetic Therapies, Inc.
Firm location: Lexington, MA

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