Recalls / Class I
Class ID-0038-2020
Class I— FDA's most serious classification, issued when there is a reasonable probability that use of or exposure to the drug will cause serious adverse health consequences or death.
Product
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
- Affected lot / code info
- 06828752, exp 12/31/2019 07110118, exp 4/30/2021 07164107, exp 12/31/2019 07200436, 07301074, exp 4/30/2021 07482212, 07630715, exp 6/30/2021 07769460, exp 4/30/2021
Why it was recalled
Defective Delivery System: potential risk of rubber stopper particles clogging the needle and leading to underdosing
Recalling firm
- Firm
- Shire Human Genetic Therapies, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 300 Shire Way, Lexington, Massachusetts 02421-2101
Distribution
- Quantity
- 8,003
- Distribution pattern
- Product was distributed throughout the United States.
Timeline
- Recall initiated
- 2019-09-12
- FDA classified
- 2019-10-01
- Posted by FDA
- 2019-10-02
- Terminated
- 2021-03-23
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0038-2020. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.