Class I
Terminated
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.
This recall has been terminated (originally issued April 30, 2014).
- Recall Initiated
- March 14, 2014
- Posted
- April 30, 2014
- Recall Number
- D-1251-2014
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 8359 vials
- Firm Location
- Lexington, MA, United States
- Official Source
- View on FDA website ↗
Reason for Recall
Presence of Particulate Matter; Particulates identified as stainless steel and barium sulfate.
Distribution
US Nationwide including Puerto Rico; Mexico, Columbia
Lot / 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.
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