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
Reported: October 2, 2019 Initiated: September 12, 2019 #D-0038-2020
Product Description
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
Reason for Recall
Defective Delivery System: potential risk of rubber stopper particles clogging the needle and leading to underdosing
Details
- Recalling Firm
- Shire Human Genetic Therapies, Inc.
- Units Affected
- 8,003
- Distribution
- Product was distributed throughout the United States.
- Location
- Lexington, MA
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Shire Human Genetic Therapies, Inc.. Units affected: 8,003.
Why was this product recalled? ▼
Defective Delivery System: potential risk of rubber stopper particles clogging the needle and leading to underdosing
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on October 2, 2019. Severity: Critical. Recall number: D-0038-2020.
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