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.