Genzyme Corporation recalls Thyrogen (thyrotropin alfa for injection), 0.9 mg/mL after reconstitution, For intramuscular injection only, Rx Only, F
Recalled March 9, 2016 · FDA recall D-0729-2016 · Genzyme
Hazard
Presence of Particulate Matter: Glass particles found in the product after reconstitution. · FDA Class II
Units
27,022 vials
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, Four vials per Carton, Carton contains 2 vials of Thyrogen and 2 vials of diluent, Storage: store at 2-8 C, Genzyme Corporation, Cambridge, MA 02142, NDC 58468-1849-04.
Manufacturer(s)
Genzyme Corporation
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →