FDA Drug recall D-1251-2014
VPRIV¿ (velaglucerase alfa for injection) , Lyophilized Powder, 400 Units/vial, Rx Only
- FDA Drug
- Class I
- terminated
- Published 2014-04-30
On 2014-04-30 the FDA classified a Class I recall of VPRIV¿ (velaglucerase alfa for injection) , Lyophilized Powder, 400 Units/vial, Rx Only by Shire Human Genetic Therapies, citing presence of Particulate Matter; Particulates identified as stainless steel and barium sulfate.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-1251-2014 |
| Classification | Class I |
| Status | terminated |
| Initiated | 2014-03-14 |
| Published | 2014-04-30 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Shire Human Genetic Therapies |
| Distribution | US |
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
Presence of Particulate Matter; Particulates identified as stainless steel and barium sulfate.
Identifiers
| ndc | 54092-701-04 |
|---|---|
| code_info | US: Lot #: FEW13-001, FEW13-002, FED13-006; Expiry: 10/15. Mexico: Lot #: FED 013-010; Expiry: 10/15. Columbia: Lot #: FED 013-011; Expiry: 10/15. |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:51 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1251-2014%22
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