Natpara — Class I drug recall D-0038-2020
Terminated recall by Shire Human Genetic Therapies, Inc., reported 2019-10-02, distributed nationwide. Defective Delivery System: potential risk of rubber stopper particles clogging the needle and leading to under
| Recall number | D-0038-2020 |
|---|---|
| Product type | Drug |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Shire Human Genetic Therapies, Inc., Lexington, MA, United States |
| Recall initiated | 2019-09-12 |
| Classified | 2019-10-01 |
| Reported by FDA | 2019-10-02 |
| Terminated | 2021-03-23 |
| Distributed | Nationwide (US) |
| Quantity | 8,003 |
| NDC | 68875-0205-02 |
| Expiration dates | 2019-12-31, 2021-04-30, 2021-06-30 |
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
Reason for recall
Defective Delivery System: potential risk of rubber stopper particles clogging the needle and leading to underdosing
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0038-2020. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.