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.

FDA recall notice · announced April 30, 2014 · Shire Human Genetic Therapies

Class I FDA/FSIS Class I: reasonable probability that use will cause serious adverse health consequences or death.

The 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.

Notes

Distribution: US Nationwide including Puerto Rico; Mexico, Columbia
Lot/code information: 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.
Quantity: 8359 vials
Status: Terminated
Products in this recall event:
- 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. (D-1251-2014)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.