Medications & Supplements/Prescription Drugs

Shire Human Genetic Therapies, Inc.: Natpara (parathyroid hormone) for Injection Recalled for Risk of Underdosing

Agency Publication Date: September 23, 2019

Summary

Shire Human Genetic Therapies is recalling 38,531 units of Natpara (parathyroid hormone) for Injection because the delivery system may be defective. Rubber particles from the cartridge stopper can break off and clog the needle, which may prevent patients from receiving their full intended dose of medication. This recall includes the 25 mcg, 50 mcg, 75 mcg, and 100 mcg dose strengths distributed across the United States. Consumers should contact their healthcare provider or pharmacist immediately for guidance and to discuss alternative treatment options.

Risk

Fragments of the rubber stopper can break off during use and clog the injection needle, which leads to the delivery of an incomplete dose of parathyroid hormone. Underdosing of this medication can cause serious health complications related to low calcium levels.

What You Should Do

Check your Natpara medication cartridges to see if they match any of the affected lot numbers and expiration dates: 25 mcg (Lots 08569357, 07983652, 08544833 with exp 4/30/2020 to 6/30/2021); 50 mcg (Lots 06628461, 06661658, 07110136, 7164106, 07761970, 07630717, 08689119, 07769458, 07983643, 08003758, 08214790, NY17002DA, NY17002DB with exp 6/30/2020 to 6/30/2021); 75 mcg (Lots 06628462, 06651000, 06661659, 07110125, 07301073, 07200435, 07482211, 07630714, NX170002DA, NX17004DA, NX17007DA, NX17007DB, NX17008DA, NX17010DA, NX17012DA with exp 12/31/2019 to 3/31/2021); or 100 mcg (Lots 06828752, 07110118, 07164107, 07200436, 07301074, 07482212, 07630715, 07769460 with exp 12/31/2019 to 6/30/2021).
Verify the NDC number on your product packaging: 68875-0202-02 (25 mcg), 68875-0203-02 (50 mcg), 68875-0204-02 (75 mcg), or 68875-0205-02 (100 mcg).
Contact your healthcare provider or pharmacist immediately to report the use of these affected lots and to obtain a different treatment plan to avoid underdosing.
Return any unused cartridges to your place of purchase for a refund and contact Shire Human Genetic Therapies, Inc. for further instructions regarding the defective delivery system.
For additional questions, contact the FDA Consumer Complaint line at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls.

Your Remedy Options

Full Refund

Pharmacy refund and healthcare consultation.

How to: Contact your healthcare provider or pharmacist for guidance. Return any unused product to the pharmacy for a refund

Affected Products

Product: Natpara (parathyroid hormone) for Injection, 25 mcg/dose, 2 pack cartridges

Model:

NDC 68875-0202-02

D-0035-2020

Lot Numbers:

08569357 (Exp 4/30/2020)

07983652 (Exp 6/30/2021)

08544833 (Exp 6/30/2021)

Date Ranges: Exp 4/30/2020, Exp 6/30/2021

Product: Natpara (parathyroid hormone) for Injection, 50 mcg, 2 pack medication cartridges

Model:

NDC 68875-0203-02

D-0036-2020

Lot Numbers:

06628461 (Exp 8/31/2020)

06661658 (Exp 10/31/2020)

07110136 (Exp 10/31/2020)

7164106 (Exp 10/31/2020)

07761970 (Exp 10/31/2020)

07630717 (Exp 12/31/2020)

08689119 (Exp 12/31/2020)

07769458 (Exp 4/30/2021)

07983643 (Exp 6/30/2021)

08003758 (Exp 6/30/2021)

08214790 (Exp 8/31/2020)

NY17002DA (Exp 6/30/2020)

NY17002DB (Exp 6/30/2020)

Date Ranges: Exp 8/31/2020, Exp 10/31/2020, Exp 12/31/2020, Exp 4/30/2021, Exp 6/30/2021, Exp 6/30/2020

Product: Natpara (parathyroid hormone) for Injection, 75 mcg, 2 pack medication cartridges

Model:

NDC 68875-0204-02

D-0037-2020

Lot Numbers:

06628462 (Exp 5/31/2020)

06651000 (Exp 9/30/2020)

06661659 (Exp 6/30/2020)

07110125 (Exp 10/31/2020)

07301073 (Exp 10/31/2020)

07200435 (Exp 7/31/2020)

07482211 (Exp 12/31/2020)

07630714 (Exp 3/31/2021)

NX170002DA (Exp 12/31/2019)

NX17004DA (Exp 3/31/2020)

NX17007DA (Exp 4/30/2020)

NX17007DB (Exp 4/30/2020)

NX17008DA (Exp 4/30/2020)

NX17010DA (Exp 6/30/2020)

NX17012DA (Exp 6/30/2020)

Date Ranges: Exp 5/31/2020, Exp 9/30/2020, Exp 6/30/2020, Exp 10/31/2020, Exp 7/31/2020, Exp 12/31/2020, Exp 3/31/2021, Exp 12/31/2019, Exp 3/31/2020, Exp 4/30/2020

Product: Natpara (parathyroid hormone) for Injection, 100 mcg, 2 pack medication cartridges

Model:

68875-0205-02

D-0038-2020

Lot Numbers:

06828752 (Exp 12/31/2019)

07110118 (Exp 4/30/2021)

07164107 (Exp 12/31/2019)

07200436 (Exp 4/30/2021)

07301074 (Exp 4/30/2021)

07482212 (Exp 6/30/2021)

07630715 (Exp 6/30/2021)

07769460 (Exp 4/30/2021)

Date Ranges: Exp 12/31/2019, Exp 4/30/2021, Exp 6/30/2021

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 83792

Status: Resolved

Manufacturer: Shire Human Genetic Therapies, Inc.

Sold By: pharmacies

Manufactured In: United States

Units Affected: 4 products (1,556; 13,897; 15,075; 8,003)

Distributed To: Nationwide

Agency Last Updated: October 2, 2019

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.

Summary

What You Should Do

Check your Natpara medication cartridges to see if they match any of the affected lot numbers and expiration dates: 25 mcg (Lots 08569357, 07983652, 08544833 with exp 4/30/2020 to 6/30/2021); 50 mcg (Lots 06628461, 06661658, 07110136, 7164106, 07761970, 07630717, 08689119, 07769458, 07983643, 08003758, 08214790, NY17002DA, NY17002DB with exp 6/30/2020 to 6/30/2021); 75 mcg (Lots 06628462, 06651000, 06661659, 07110125, 07301073, 07200435, 07482211, 07630714, NX170002DA, NX17004DA, NX17007DA, NX17007DB, NX17008DA, NX17010DA, NX17012DA with exp 12/31/2019 to 3/31/2021); or 100 mcg (Lots 06828752, 07110118, 07164107, 07200436, 07301074, 07482212, 07630715, 07769460 with exp 12/31/2019 to 6/30/2021).

Verify the NDC number on your product packaging: 68875-0202-02 (25 mcg), 68875-0203-02 (50 mcg), 68875-0204-02 (75 mcg), or 68875-0205-02 (100 mcg).

Contact your healthcare provider or pharmacist immediately to report the use of these affected lots and to obtain a different treatment plan to avoid underdosing.

Return any unused cartridges to your place of purchase for a refund and contact Shire Human Genetic Therapies, Inc. for further instructions regarding the defective delivery system.

For additional questions, contact the FDA Consumer Complaint line at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls.

Affected Products

Product: Natpara (parathyroid hormone) for Injection, 25 mcg/dose, 2 pack cartridges

Model:

NDC 68875-0202-02

D-0035-2020

Lot Numbers:

08569357 (Exp 4/30/2020)

07983652 (Exp 6/30/2021)

08544833 (Exp 6/30/2021)

Date Ranges: Exp 4/30/2020, Exp 6/30/2021

Product: Natpara (parathyroid hormone) for Injection, 50 mcg, 2 pack medication cartridges

Model:

NDC 68875-0203-02

D-0036-2020

Lot Numbers:

06628461 (Exp 8/31/2020)

06661658 (Exp 10/31/2020)

07110136 (Exp 10/31/2020)

7164106 (Exp 10/31/2020)

07761970 (Exp 10/31/2020)

07630717 (Exp 12/31/2020)

08689119 (Exp 12/31/2020)

07769458 (Exp 4/30/2021)

07983643 (Exp 6/30/2021)

08003758 (Exp 6/30/2021)

08214790 (Exp 8/31/2020)

NY17002DA (Exp 6/30/2020)

NY17002DB (Exp 6/30/2020)

Date Ranges: Exp 8/31/2020, Exp 10/31/2020, Exp 12/31/2020, Exp 4/30/2021, Exp 6/30/2021, Exp 6/30/2020

Product: Natpara (parathyroid hormone) for Injection, 75 mcg, 2 pack medication cartridges

Model:

NDC 68875-0204-02

D-0037-2020

Lot Numbers:

06628462 (Exp 5/31/2020)

06651000 (Exp 9/30/2020)

06661659 (Exp 6/30/2020)

07110125 (Exp 10/31/2020)

07301073 (Exp 10/31/2020)

07200435 (Exp 7/31/2020)

07482211 (Exp 12/31/2020)

07630714 (Exp 3/31/2021)

NX170002DA (Exp 12/31/2019)

NX17004DA (Exp 3/31/2020)

NX17007DA (Exp 4/30/2020)

NX17007DB (Exp 4/30/2020)

NX17008DA (Exp 4/30/2020)

NX17010DA (Exp 6/30/2020)

NX17012DA (Exp 6/30/2020)

Date Ranges: Exp 5/31/2020, Exp 9/30/2020, Exp 6/30/2020, Exp 10/31/2020, Exp 7/31/2020, Exp 12/31/2020, Exp 3/31/2021, Exp 12/31/2019, Exp 3/31/2020, Exp 4/30/2020

Product: Natpara (parathyroid hormone) for Injection, 100 mcg, 2 pack medication cartridges

Model:

68875-0205-02

D-0038-2020

Lot Numbers:

06828752 (Exp 12/31/2019)

07110118 (Exp 4/30/2021)

07164107 (Exp 12/31/2019)

07200436 (Exp 4/30/2021)

07301074 (Exp 4/30/2021)

07482212 (Exp 6/30/2021)

07630715 (Exp 6/30/2021)

07769460 (Exp 4/30/2021)

Date Ranges: Exp 12/31/2019, Exp 4/30/2021, Exp 6/30/2021