FDA Recall D-0036-2020

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, 50 mcg, 2 pack medication cartridges, Rx only, For subcutaneous use only, Manufactured for: Shire-NPS Pharmaceuticals, Inc., Lexington, MA NDC 68875-0203-02

Lot / code: 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

Quantity: 13,897

Reason for recall

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

Recall record

Recall number: D-0036-2020
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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