FDA recall D-0730-2016

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.

Reason for recall

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

Distribution

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

Key facts

Status

Terminated

Initiation date

2016-02-16

Report date

2016-03-09

Termination date

2017-03-02

Voluntary/Mandated

Voluntary: Firm initiated

Location

Cambridge, MA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0730-2016