The Recall Desk
SevereFDA (Drugs)·D-0037-2020·Announced 2019-10-02

Natpara Injection Cartridges Recalled for Potential Needle Clogging

Shire is recalling Natpara (parathyroid hormone) injection cartridges because rubber stopper particles may clog the needle, leading to underdosing.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The agency classification is FDA Class I, which mandates a minimum severity score of 4 according to the rubric.

Plain-English summary

Shire Human Genetic Therapies, Inc. is recalling Natpara (parathyroid hormone) for Injection, 75 mcg, 2 pack medication cartridges. The recall is due to a defective delivery system where rubber stopper particles may clog the needle, potentially leading to underdosing of the medication.

The affected product is prescription-only and intended for subcutaneous use. The recall covers 15,075 units distributed throughout the United States. Specific lot numbers and expiration dates are listed in the official recall documentation.

Patients and healthcare providers should stop using the affected cartridges and contact their healthcare provider or Shire for further instructions on how to obtain replacement medication or manage the recall.

The recalled product

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
Manufacturer
Shire Human Genetic Therapies, Inc.
Category
Drug — Injection
Hazard
Affected units
15,075

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (15)

  • 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

Distribution scope not specified by the agency.

Part of a larger recall action

This product is one of 4 recalled by Shire Human Genetic Therapies, Inc. under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 4 products in this recall →

Related recalls

Same manufacturer · Shire Human Genetic Therapies, Inc.

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Same hazard · underdosing

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