D-1251-2014 Class I Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- April 30, 2014
- Initiation Date
- March 14, 2014
- Termination Date
- August 31, 2016
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 8359 vials
Product Description
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.
Distribution Pattern
US Nationwide including Puerto Rico; Mexico, Columbia
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.