Product: 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.
Reason for recall: Presence of Particulate Matter: Glass particles found in the product after reconstitution.
Recall initiated: 20160216
Status: Terminated
Classification: Class II
Recall type: Voluntary: Firm initiated