Drug product
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
D-0038-2020
Product summary
- Event
- Event 83792
- Status
- Terminated
- Classification
- Class I
- Quantity
- 8,003
- Official record key
drug-enforcement:D-0038-2020
Official wording
Reason: Defective Delivery System: potential risk of rubber stopper particles clogging the needle and leading to underdosing
Code information: 06828752, exp 12/31/2019 07110118, exp 4/30/2021 07164107, exp 12/31/2019 07200436, 07301074, exp 4/30/2021 07482212, 07630715, exp 6/30/2021 07769460, exp 4/30/2021
Distribution pattern: Product was distributed throughout the United States.
Derived failure modes
-
Unknown
Defective Delivery System: potential risk of rubber stopper particles clogging the needle and leading to underdosing