Recalls / Class II
Class IID-0730-2016
Product
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.
- Brand name
- Thyrogen
- Generic name
- Thyrotropin Alfa
- Active ingredient
- Thyrotropin Alfa
- Route
- Intramuscular
- NDCs
- 58468-0030, 58468-1849
- FDA application
- BLA020898
- Affected lot / code info
- Lot #s: E4029Y03, E4029Y04, E4029Y06, E4029Y07, Exp 12/2017
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
- 4669 Cartons
- 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-0730-2016. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.