March 2014 FDA Recall Vpriv by Shire Human Genetic Therapies, Inc.
D-1251-2014 - Presence of Particulate Matter; Particulates identified as stainless steel and barium sulfate.

This Class I drug recall was voluntarily initiated by Shire Human Genetic Therapies, Inc. on March 14, 2014 for the product Vpriv. The FDA reported the reason for recall as presence of particulate matter; particulates identified as stainless steel and barium sulfate.. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-1251-2014

Reason for Recall
Presence of Particulate Matter; Particulates identified as stainless steel and barium sulfate.
Initiated
03-14-2014
Reported
04-30-2014
Quantity
8359 vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
67690
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class I - is a situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Shire Human Genetic Therapies, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
US Nationwide including Puerto Rico; Mexico, Columbia
Termination Date About Termination Date
Date that FDA officially terminated the recall.
08-31-2016
Product Description About Product Description
Full technical description of 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.

Batch or Lot Expiration Information

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.

Affected Packages Involved in this Recall

54092-701-04 Vpriv