Reported Apr 30, 2014 · Terminated

VPRIV¿ (velaglucerase alfa for injection) , Lyophilized Powder, 400 Units/vial, Rx Only. Shire Human Genetic Therapies,…

Shire Human Genetic Therapies, Inc.

High riskUsing this product could cause serious injury, illness or death — stop using it now.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Shire Human Genetic Therapies, Inc. · 300-400 Shire Way · Lexington, MA · 02421-2101

Is this the product you have?

  • VPRIV¿ (velaglucerase alfa for injection) , Lyophilized Powder, 400 Units/vial, Rx Only. Shire Human Genetic Therapies, Inc. 300 Shire Way, Lexington, MA 02421
  • NDC54092-701-04
Lot codes and dates
  • US
    • Lot #: FEW13-001
    • FEW13-002
    • FED13-006
  • Expiry10/15
  • MexicoLot #: FED 013-010
  • Expiry10/15
  • ColumbiaLot #: FED 013-011
  • Expiry10/15
Amount recalled
8359 vials

Where it was sold

  • Nationwide
  • PR

Why it was recalled

Stop using this product now

Presence of Particulate Matter; Particulates identified as stainless steel and barium sulfate.

Using this product could cause serious injury, illness or death — stop using it now.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA drug enforcement) notice

Notice updated Aug 31, 2016 · Data as of Sep 19, 5:05 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.