CLASS I Drug recall · Reported 2 Oct 2019 · FDA Enforcement Report

Natpara (parathyroid hormone) for Injection recalled

Shire Human Genetic Therapies is recalling Natpara (parathyroid hormone) for Injection, 75 mcg medication cartridges, distributed nationwide in the US. The recall was initiated on 12 Sep 2019 and the FDA has classified it as Class I.

Check your package

Lot, batch or date codes06628462, 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 recalled15,075

Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.

Recall details

Recall number: D-0037-2020
FDA event ID: 83792
Recalling firm: Shire Human Genetic Therapies, Lexington, MA
Classification: Class I
Status: Terminated
Recall initiated: 12 Sep 2019
FDA classified: 1 Oct 2019
Reported: 2 Oct 2019
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Particulate Matter
Drug class: Thyroid Medication

Timeline

12 Sep 2019	Recall initiated by company
1 Oct 2019	Classified by FDA	+19 days
2 Oct 2019	Published in enforcement report	+1 day

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

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

Product as listed by the FDA

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

Where it was distributed

Product was distributed throughout the United States.

Nationwide

Questions about this recall

Why was it recalled?

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

Which lots are affected?

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

Where was it sold?

Product was distributed throughout the United States.

What should I do if I have it?

Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.

What does Class I mean?

Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

3 other products · FDA event 83792

This product is part of a recall event; the main page for the event is Natpara (parathyroid hormone) for Injection, 25 mcg/dose cartridges recalled.

Reported	Class	Recall	Company	Reason	Where
2 Oct 2019	CLASS I	Natpara (parathyroid hormone) for Injection, 25 mcg/dose cartridges recalled	Shire Human Genetic Therapies	Particulate Matter	Nationwide
2 Oct 2019	CLASS I	Natpara (parathyroid hormone) for Injection recalled	Shire Human Genetic Therapies	Particulate Matter	Nationwide
2 Oct 2019	CLASS I	Natpara (parathyroid hormone) for Injection recalled	Shire Human Genetic Therapies	Particulate Matter	Nationwide

More recalls from Shire Human Genetic Therapies

All 5

Reported	Class	Recall	Company	Reason	Where
2 Oct 2019Drug	CLASS I	Natpara (parathyroid hormone) for Injection recalled	Shire Human Genetic Therapies	Particulate Matter	Nationwide
2 Oct 2019Drug	CLASS I	Natpara (parathyroid hormone) for Injection recalled	Shire Human Genetic Therapies	Particulate Matter	Nationwide
2 Oct 2019Drug	CLASS I	Natpara (parathyroid hormone) for Injection, 25 mcg/dose cartridges recalled	Shire Human Genetic Therapies	Particulate Matter	Nationwide
30 Apr 2014Drug	CLASS I	Vpriv¿ (velaglucerase alfa for injection) , Lyophilized Powder recalledVpriv	Shire Human Genetic Therapies	Particulate Matter	Nationwide

Other Natpara (parathyroid Hormone recalls

All 4

Reported	Class	Recall	Company	Reason	Where
2 Oct 2019Drug	CLASS I	Natpara (parathyroid hormone) for Injection recalled	Shire Human Genetic Therapies	Particulate Matter	Nationwide
2 Oct 2019Drug	CLASS I	Natpara (parathyroid hormone) for Injection recalled	Shire Human Genetic Therapies	Particulate Matter	Nationwide
2 Oct 2019Drug	CLASS I	Natpara (parathyroid hormone) for Injection, 25 mcg/dose cartridges recalled	Shire Human Genetic Therapies	Particulate Matter	Nationwide