D-0035-2020 Class I Terminated
FDA drug recall D-0035-2020 was initiated by Shire Human Genetic Therapies, Inc. on Sep 12, 2019 and is designated Class I. Reason for recall: Defective Delivery System: potential risk of rubber stopper particles clogging the needle and leading to underdosing The recall status is terminated (terminated Mar 23, 2021). Affected quantity: 1,556.
Recall details
- Product Type
- Drugs
- Report Date
- Oct 2, 2019
- Initiation Date
- Sep 12, 2019
- Termination Date
- Mar 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
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0035-2020
- openFDA file date
- Nov 10, 2026
- Loaded by RegDataLab
- Nov 11, 2026