Why it was recalled
Presence of Particulate Matter: Glass particles found in the product after reconstitution.
Product description
Thyrogen (thyrotropin alfa for injection), 0.9 mg/mL after reconstitution, For intramuscular injection only, Rx Only, Four vials per Carton, Carton contains 2 vials of Thyrogen and 2 vials of diluent, Storage: store at 2-8 C, Genzyme Corporation, Cambridge, MA 02142, NDC 58468-1849-04.
Lot numbers, UPCs & expiration codes
Lot #: E4029Y02 (carton), E4029 (vial) Exp 09/2016
Where it was sold
Nationwide, Puerto Rico and Malaysia, Taiwan, Brazil, and Israel.
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0729-2016
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Feb 16, 2016
- FDA report date
- Mar 9, 2016
- Quantity
- 27,022 vials
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Genzyme Corporation
Original FDA data
Every field from FDA enforcement report D-0729-2016, exactly as published.
Show all FDA fields
- City
- Cambridge
- State
- MA
- Status
- Terminated
- Country
- United States
- Event ID
- 73301
- Address
- 500 Kendall Street
- Address (line 2)
- 675 West Kendall/55 Cambridge Parkway
- Code information
- Lot #: E4029Y02 (carton), E4029 (vial) Exp 09/2016
- Postal code
- 02142-1108
- Report date
- Mar 9, 2016
- Product type
- Drugs
- Recall number
- D-0729-2016
- Classification
- Class II
- Recalling firm
- Genzyme Corporation
- Product quantity
- 27,022 vials
- Termination date
- Mar 2, 2017
- Reason for recall
- Presence of Particulate Matter: Glass particles found in the product after reconstitution.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Thyrogen (thyrotropin alfa for injection), 0.9 mg/mL after reconstitution, For intramuscular injection only, Rx Only, Four vials per Carton, Carton contains 2 vials of Thyrogen and 2 vials of diluent, Storage: store at 2-8 C, Genzyme Corporation, Cambridge, MA 02142, NDC 58468-1849-04.
- Distribution pattern
- Nationwide, Puerto Rico and Malaysia, Taiwan, Brazil, and Israel.
- Recall initiation date
- Feb 16, 2016
- Initial firm notification
- Telephone
- Center classification date
- Feb 26, 2016