Drug product
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
D-0036-2020
Product summary
- Event
- Event 83792
- Status
- Terminated
- Classification
- Class I
- Quantity
- 13,897
- Official record key
drug-enforcement:D-0036-2020
Official wording
Reason: Defective Delivery System: potential risk of rubber stopper particles clogging the needle and leading to underdosing
Code information: 06628461, exp 8/31/2020 06661658, 07110136, 7164106, 07761970 exp 10/31/2020 07630717, 08689119, exp 12/31/2020 07769458, exp 4/30/2021 07983643, 08003758, exp 6/30/2021 08214790, exp 8/31/2020 NY17002DA, NY17002DB, exp 6/30/2020
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