Shire Human Genetic Therapies, Inc. recalls Natpara (parathyroid hormone) for Injection, 50 mcg, 2 pack medication cartridges, Rx only, For subcutaneous use only,…
- Recall date
- September 12, 2019
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- D-0036-2020
- FDA classification
- Class I
- Brand / firm
- Shire Human Genetic Therapies, Inc.
- Sold / distributed
- Product was distributed throughout the United States.
Why it was recalled
Defective Delivery System: potential risk of rubber stopper particles clogging the needle and leading to underdosing
Class I is the FDA’s most serious recall level: there is a reasonable probability that using this product will cause serious harm or death.
What was recalled
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
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