Drug product
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
D-0035-2020
Product summary
- Event
- Event 83792
- Status
- Terminated
- Classification
- Class I
- Quantity
- 1,556
- Official record key
drug-enforcement:D-0035-2020
Official wording
Reason: Defective Delivery System: potential risk of rubber stopper particles clogging the needle and leading to underdosing
Code information: 08569357, exp 4/30/2020; 07983652, 08544833, exp 6/30/2021
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