VPRIV¿ — Class I drug recall D-1251-2014
Terminated recall by Shire Human Genetic Therapies, Inc., reported 2014-04-30, distributed nationwide. Presence of Particulate Matter; Particulates identified as stainless steel and barium sulfate.
| Recall number | D-1251-2014 |
|---|---|
| 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 | 2014-03-14 |
| Classified | 2014-04-18 |
| Reported by FDA | 2014-04-30 |
| Terminated | 2016-08-31 |
| Distributed | Nationwide (US) |
| Countries outside the US | MX |
| Quantity | 8,359 vials |
| Reason classes | specification failure |
| NDC | 54092-0701, 54092-0701-04 |
| Lot numbers | 013-010, 013-011, 10/15, FED13-006, FEW13-001, FEW13-002 |
Product
VPRIV¿ (velaglucerase alfa for injection) , Lyophilized Powder, 400 Units/vial, Rx Only. Shire Human Genetic Therapies, Inc. 300 Shire Way, Lexington, MA 02421. NDC: 54092-701-04.
Reason for recall
Presence of Particulate Matter; Particulates identified as stainless steel and barium sulfate.
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-1251-2014. 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.