Drug 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.
D-0729-2016
Product summary
- Event
- Event 73301
- Status
- Terminated
- Classification
- Class II
- Quantity
- 27,022 vials
- Official record key
drug-enforcement:D-0729-2016
Official wording
Reason: Presence of Particulate Matter: Glass particles found in the product after reconstitution.
Code information: Lot #: E4029Y02 (carton), E4029 (vial) Exp 09/2016
Distribution pattern: Nationwide, Puerto Rico and Malaysia, Taiwan, Brazil, and Israel.
Derived failure modes
-
Foreign material or chemical contamination
Particulate Matter