Recalls / Class II
Class IID-0729-2016
Product
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.
- Affected lot / code info
- Lot #: E4029Y02 (carton), E4029 (vial) Exp 09/2016
Why it was recalled
Presence of Particulate Matter: Glass particles found in the product after reconstitution.
Recalling firm
- Firm
- Genzyme Corporation
- Notification channel
- Telephone
- Type
- Voluntary: Firm initiated
- Address
- 500 Kendall Street, 675 West Kendall/55 Cambridge Parkway, Cambridge, Massachusetts 02142-1108
Distribution
- Quantity
- 27,022 vials
- Distribution pattern
- Nationwide, Puerto Rico and Malaysia, Taiwan, Brazil, and Israel.
Timeline
- Recall initiated
- 2016-02-16
- FDA classified
- 2016-02-26
- Posted by FDA
- 2016-03-09
- Terminated
- 2017-03-02
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0729-2016. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.