Recalls / Class I
Class ID-0035-2020
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, 25 mcg/dose, 2 pack cartridges, Rx only, For subcutaneous use only, Manufactured for: Shire-NPS Pharmaceuticals, Inc., Lexington, MA NDC 68875-0202-02
- Affected lot / code info
- 08569357, exp 4/30/2020; 07983652, 08544833, exp 6/30/2021
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
- 1,556
- 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-0035-2020. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.