Vpriv Injection, Powder, Lyophilized, For Solution
FDA Recall NDC 54092-701
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 1 recorded enforcement report(s) associated with Vpriv (NDC 54092-701). A significant event, classified as Class I, was initiated on Mar 14, 2014 by Takeda Pharmaceuticals America, Inc.. The reported reason for this action was: "Presence of Particulate Matter; Particulates identified as stainless steel and barium sulfate."
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
Reported Recall Events
March 2014 Class I Recall: Presence of Particulate Matter; Particulates identified as stainless steel and barium sulfate.
Recall Number
Class I Terminated
Presence of Particulate Matter; Particulates identified as stainless steel and barium sulfate.
Mar 14, 2014
Apr 30, 2014
8359 vials
Recall Profile & Regulatory Data
Event ID
67690
Classification
Class I
Enforcement Status
Terminated
Recalling Firm
Shire Human Genetic Therapies, Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
US Nationwide including Puerto Rico; Mexico, Columbia
Termination Date
Aug 31, 2016
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.
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
54092-701-04Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
