D-0035-2020 Class I Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- October 2, 2019
- Initiation Date
- September 12, 2019
- Termination Date
- March 23, 2021
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1,556
Product Description
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
Reason for Recall
Defective Delivery System: potential risk of rubber stopper particles clogging the needle and leading to underdosing
Distribution Pattern
Product was distributed throughout the United States.
Code Information
08569357, exp 4/30/2020; 07983652, 08544833, exp 6/30/2021