Drug recall D-0729-2016

Class II Terminated reported Mar 9, 2016

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.

Reason for recall

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

Lots and codes

Lot #: E4029Y02 (carton), E4029 (vial) Exp 09/2016

Recall details

Recalling firm
Genzyme Corporation, Cambridge, MA
Quantity
27,022 vials
Distribution
Nationwide, Puerto Rico and Malaysia, Taiwan, Brazil, and Israel.
Type
Voluntary: Firm initiated
Recall initiated
February 16, 2016
Terminated
March 2, 2017