Recalls / Class I
Class ID-0037-2020
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, 75 mcg, 2 pack medication cartridges, Rx only, For subcutaneous use only, Manufactured for: Shire-NPS Pharmaceuticals, Inc., Lexington, MA NDC 68875-0204-02
- Affected lot / code info
- 06628462, exp 5/31/2020 06651000, exp 9/30/2020 06661659, exp 6/30/2020 07110125, 07301073, exp 10/31/2020 07200435, 7/31/2020 07482211, exp 12/31/2020 07630714, exp 3/31/2021 NX170002DA, exp 12/31/2019 NX17004DA, exp 3/31/2020 NX17007DA, NX17007DB, NX17008DA exp 4/30/2020 NX17010DA, NX17012DA, exp 6/30/2020
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
- 15,075
- 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-0037-2020. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.