FDAFDA · Food and drugs·Recall number D-1251-2014
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.
Published April 30, 2014 · Recall initiated: March 14, 2014
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Presence of Particulate Matter; Particulates identified as stainless steel and barium sulfate.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Brand
- VPRIV
- Manufacturer
- Shire Human Genetic Therapies, Inc.
- Distributor
- US Nationwide including Puerto Rico; Mexico, Columbia
- Lot
- 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.
- Risk classification
- Class I
- Area (FDA)
- drug
- Country
- United States
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