Natpara (parathyroid hormone) for Injection, 25 mcg/dose, 2 pack cartridges, Rx only, For subcuta...

FDA Drug Recall #D-0035-2020 — Class I — September 12, 2019

Recall Summary

Recall Number D-0035-2020
Classification Class I — Serious risk
Date Initiated September 12, 2019
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Shire Human Genetic Therapies, Inc.
Location Lexington, MA
Product Type Drugs
Quantity 1,556

Product Description

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

Reason for Recall

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

Distribution Pattern

Product was distributed throughout the United States.

Lot / Code Information

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

Other Recalls from Shire Human Genetic Therapies, Inc.

Recall # Classification Product Date
D-0038-2020 Class I Natpara (parathyroid hormone) for Injection, 10... Sep 12, 2019
D-0037-2020 Class I Natpara (parathyroid hormone) for Injection, 75... Sep 12, 2019
D-0036-2020 Class I Natpara (parathyroid hormone) for Injection, 50... Sep 12, 2019
D-1251-2014 Class I VPRIV¿ (velaglucerase alfa for injection) , Lyo... Mar 14, 2014

Frequently Asked Questions

Stop taking the medication and contact your pharmacist or doctor immediately. For Class I recalls, this is urgent. For Class II or III recalls, consult your doctor before stopping — abruptly discontinuing certain medications (blood pressure drugs, antidepressants, diabetes medications) can be more harmful than continuing while arranging a replacement. Check whether the recall applies to your specific lot number and expiration date. Return the product to your pharmacy and report any adverse effects to FDA MedWatch at 1-800-FDA-1088.

Not necessarily. Many drug recalls are initiated because of quality system failures or test results that suggest a product might not meet specifications — even if no patients have reported harm. The FDA uses a precautionary approach: if there is reason to believe quality standards were not met, a recall is required regardless of whether adverse effects have been reported. Class I recalls typically involve a reasonable probability of harm; Class II recalls may cause temporary health issues; Class III recalls are for products unlikely to cause adverse health consequences but that still violate regulations.

Pharmacies typically receive recall notices directly from drug wholesalers and manufacturers within days of the recall being announced. Your pharmacist can look up whether any product in your prescription history matches a recalled lot number. For current recalls, the FDA publishes updates at FDA.gov/safety/recalls-market-withdrawals-safety-alerts and sends MedWatch email alerts for significant drug safety issues. You can sign up for MedWatch alerts at FDA.gov. Most major pharmacy chains also have their own recall notification systems that automatically alert pharmacists when a recalled product is in their inventory.

What Should You Do?

Stop using this medication if affected by this recall. Contact your pharmacist or prescribing doctor immediately for guidance. Do not flush medications — use a drug take-back program.