US Drug Recall Register
Class II · Moderate risk Terminated Initiated Feb 16, 2016 (11 years ago)

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

Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.

Why it was recalled

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

What was recalled

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, Storage: store at 2-8 C, Manufactured by: Genzyme Corporation, Northborough, MA 01532 USA, Marketing Authorization holder: Sanofi-Aventis, NDC 58468-0030-2.

Recalling firm
Genzyme Corporation
NDC code
58468-0030-2
Origin
MA, United States
Initiated by
Voluntary: Firm initiated
FDA recall number
D-0730-2016

What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.