Drug recall D-0730-2016
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.
Reason for recall
Presence of Particulate Matter: Glass particles found in the product after reconstitution.
Lots and codes
Lot #s: E4029Y03, E4029Y04, E4029Y06, E4029Y07, Exp 12/2017
Recall details
- Recalling firm
- Genzyme Corporation, Cambridge, MA
- Quantity
- 4669 Cartons
- Distribution
- Nationwide, Puerto Rico and Malaysia, Taiwan, Brazil, and Israel.
- Type
- Voluntary: Firm initiated
- Recall initiated
- February 16, 2016
- Terminated
- March 2, 2017
Related products
- Thyrogen – drug information
- NDC 58468-0030 Thyrogen · Thyrotropin Alfa .9 mg/mL · Genzyme Corporation