Reported Mar 9, 2016 · Terminated

Thyrogen (thyrotropin alfa for injection), 0.9 mg/mL after reconstitution, For intramuscular injection only, Rx Only,…

Genzyme Corporation

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

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: Genzyme Corporation · 500 Kendall Street · Cambridge, MA · 02142-1108

Is this the product you have?

  • Thyrogen (thyrotropin alfa for injection), 0.9 mg/mL after reconstitution, For intramuscular injection only, Rx Only, Two vials per Carton, Carton contains 2 vials of Thyrogen, Dilute with Sterile Water for Injection
  • Storagestore at 2-8 C
  • Manufactured byGenzyme Corporation, Northborough, MA 01532 USA
  • Marketing Authorization holderSanofi-Aventis, NDC 58468-0030-2
Lot codes and dates
    • Lot #s: E4029Y03
    • E4029Y04
    • E4029Y06
    • E4029Y07
    • Exp 12/2017
Amount recalled
4669 Cartons

This recall covers 2 products

The agency filed one notice per product. You are reading one of them; the other one is below.

Where it was sold

  • Nationwide
  • PR

Why it was recalled

Presence of Particulate Matter: Glass particles found in the product after reconstitution.

This product could cause temporary or reversible health problems — stop using it.

Want the full recall guide?

The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.

Free recall alerts

Get alerted about new Genzyme Corporation recalls

One email when a matching recall is published. No account, no cost, unsubscribe in one click.

Where this came from

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

Read the FDA (openFDA drug enforcement) notice

Notice updated Mar 2, 2017 · Data as of Sep 19, 7:00 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.