Lexington, MA, United States
Shire Human Genetic Therapies, Inc. recalls
1 recall recorded since 2018, most recently on 12 September 2019. None are listed as ongoing. Status and classification are as published by the FDA.
Recalls1
Ongoing (FDA)0
Terminated or completed1
Class I (FDA)1
Terminated Class I Drugs
- Recall started
- 12 September 2019
- Terminated
- 23 March 2021
- Reason
- Defective Delivery System: potential risk of rubber stopper particles clogging the needle and leading to underdosing
- Distribution
- Product was distributed throughout the United States.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- D-0035-2020, D-0038-2020, D-0037-2020, D-0036-2020
- 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
- Natpara (parathyroid hormone) for Injection, 100 mcg, 2 pack medication cartridges, Rx only, For subcutaneous use only, Manufactured for: Shire-NPS Pharmaceuticals, Inc., Lexington, MA 68875-0205-02
- 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
- Natpara (parathyroid hormone) for Injection, 50 mcg, 2 pack medication cartridges, Rx only, For subcutaneous use only, Manufactured for: Shire-NPS Pharmaceuticals, Inc., Lexington, MA NDC 68875-0203-02
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.