Genzyme Corporation recalls Thyrogen (thyrotropin alfa for injection), 0.9 mg/mL after reconstitution, For intramuscular injection only, Rx Only, Tw
Recalled March 9, 2016 · FDA recall D-0730-2016 · Genzyme
Hazard
Presence of Particulate Matter: Glass particles found in the product after reconstitution. · FDA Class II
Units
4669 Cartons
Sold at
Nationwide, Puerto Rico and Malaysia, Taiwan, Brazil, and Israel.
Description
Presence of Particulate Matter: Glass particles found in the product after reconstitution.
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.
Manufacturer(s)
Genzyme Corporation
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →