D-0730-2016 Class II Terminated
FDA drug recall D-0730-2016 was initiated by Genzyme Corporation on February 16, 2016 and is designated Class II. Reason for recall: Presence of Particulate Matter: Glass particles found in the product after reconstitution. The recall status is terminated (terminated March 2, 2017). Affected quantity: 4669 Cartons.
Recall Details
- Product Type
- Drugs
- Report Date
- March 9, 2016
- Initiation Date
- February 16, 2016
- Termination Date
- March 2, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 4669 Cartons
Product Description
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.
Distribution Pattern
Nationwide, Puerto Rico and Malaysia, Taiwan, Brazil, and Israel.
Code Information
Lot #s: E4029Y03, E4029Y04, E4029Y06, E4029Y07, Exp 12/2017