Genzyme Corporation recalls Thyrogen (thyrotropin alfa for injection), 0.9 mg/mL after reconstitution, For intramuscular injection only, Rx Only, T…

Recall date

February 16, 2016

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

D-0730-2016

FDA classification

Class II

Brand / firm

Genzyme Corporation

Sold / distributed

Nationwide, Puerto Rico and Malaysia, Taiwan, Brazil, and Israel.

Why it was recalled

Presence of Particulate Matter: Glass particles found in the product after reconstitution.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.