FDA-Drug2016-03-09Class II
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.
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
27,022 vials
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, 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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0729-2016Don't want to check this manually?
We email you a Sunday digest of new federal recalls relevant to parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.
Get the Sunday Brief