FDA-Drug2016-03-09Class II
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.
Genzyme Corporation
Hazard
Presence of Particulate Matter: Glass particles found in the product after reconstitution.
Sold states
Nationwide, Puerto Rico and Malaysia, Taiwan, Brazil, and Israel.
Affected count
4669 Cartons
Manufactured in
500 Kendall Street, 675 West Kendall/55 Cambridge Parkway, Cambridge, MA, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0730-2016Don't want to check this manually?
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