Class II
Terminated
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.
- Company
- Genzyme Corporation
- Recall Initiated
- February 16, 2016
- Posted
- March 9, 2016
- Recall Number
- D-0729-2016
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 27,022 vials
- Firm Location
- Cambridge, MA, United States
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.
Lot / Code Info
Lot #: E4029Y02 (carton), E4029 (vial) Exp 09/2016
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