FDA Recall D-0035-2020

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, 25 mcg/dose, 2 pack cartridges, Rx only, For subcutaneous use only, Manufactured for: Shire-NPS Pharmaceuticals, Inc., Lexington, MA NDC 68875-0202-02

Lot / code: 08569357, exp 4/30/2020; 07983652, 08544833, exp 6/30/2021

Quantity: 1,556

Reason for recall

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

Recall record

Recall number: D-0035-2020
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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