Multi event Drug Recall Enforcement Report Class II voluntary initiated by Genzyme Corporation, originally initiated on 02-16-2016 for the 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. The product was recalled due to presence of particulate matter: glass particles found in the product after reconstitution.. The product was distributed nationwide and the recall is currently terminated.
Recall Enforcement Reports
| Recall Number |
Recall Initiation Date |
Report Date |
Recall Classification |
Quantity |
Product Description |
Recall Reason |
Status |
| D-0729-2016 | 02-16-2016 | 03-09-2016 | Class II | 27,022 vials | 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. | Presence of Particulate Matter: Glass particles found in the product after reconstitution. | Terminated |
| D-0730-2016 | 02-16-2016 | 03-09-2016 | Class II | 4669 Cartons | 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. | Presence of Particulate Matter: Glass particles found in the product after reconstitution. | Terminated |
Recalled Products
