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.
Class I - DangerousWhat Should You Do?
- Check if you have this product: Lot #s: E4029Y03, E4029Y04, E4029Y06, E4029Y07, Exp 12/2017
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- Genzyme Corporation
- Reason for Recall:
- Presence of Particulate Matter: Glass particles found in the product after reconstitution.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full 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.
Product Codes/Lot Numbers:
Lot #s: E4029Y03, E4029Y04, E4029Y06, E4029Y07, Exp 12/2017
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: D-0730-2016
Related Recalls
Labeling: Incorrect or Missing Package Insert.
Labeling: Incorrect or Missing Lot and/or Exp Date
Presence of Particulate Matter: Glass particles found in the product after reconstitution.