Drug 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.
D-0730-2016
Product summary
- Event
- Event 73301
- Status
- Terminated
- Classification
- Class II
- Quantity
- 4669 Cartons
- Official record key
drug-enforcement:D-0730-2016
Official wording
Reason: Presence of Particulate Matter: Glass particles found in the product after reconstitution.
Code information: Lot #s: E4029Y03, E4029Y04, E4029Y06, E4029Y07, Exp 12/2017
Distribution pattern: Nationwide, Puerto Rico and Malaysia, Taiwan, Brazil, and Israel.
Derived failure modes
-
Foreign material or chemical contamination
Particulate Matter