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: E4029Y03E4029Y04E4029Y06E4029Y07Exp 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.
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