FDAFDA · Food and drugs·Recall number D-0730-2016
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.
Published March 9, 2016 · Recall initiated: February 16, 2016
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Presence of Particulate Matter: Glass particles found in the product after reconstitution.
What to do
Voluntary: Firm initiated · Telephone
Recall details
- Brand
- THYROGEN
- Manufacturer
- Genzyme Corporation
- Distributor
- Nationwide, Puerto Rico and Malaysia, Taiwan, Brazil, and Israel.
- Lot
- Lot #s: E4029Y03, E4029Y04, E4029Y06, E4029Y07, Exp 12/2017
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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