Shire Human Genetic Therapies, Inc.
FDA Regulatory Profile
Summary
- Total Recalls
- 5 (5 Class I)
- 510(k) Clearances
- 0
- Inspections
- 32
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| D-0037-2020 | Class I | Natpara (parathyroid hormone) for Injection, 75 mcg, 2 pack medication cartridges, Rx only, For subc | September 12, 2019 |
| D-0036-2020 | Class I | Natpara (parathyroid hormone) for Injection, 50 mcg, 2 pack medication cartridges, Rx only, For subc | September 12, 2019 |
| D-0038-2020 | Class I | Natpara (parathyroid hormone) for Injection, 100 mcg, 2 pack medication cartridges, Rx only, For sub | September 12, 2019 |
| D-0035-2020 | Class I | Natpara (parathyroid hormone) for Injection, 25 mcg/dose, 2 pack cartridges, Rx only, For subcutaneo | September 12, 2019 |
| D-1251-2014 | Class I | VPRIV¿ (velaglucerase alfa for injection) , Lyophilized Powder, 400 Units/vial, Rx Only. Shire Human | March 14, 2014 |