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.
Reported: March 9, 2016 Initiated: February 16, 2016 #D-0729-2016
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.
Reason for Recall
Presence of Particulate Matter: Glass particles found in the product after reconstitution.
Details
- Recalling Firm
- Genzyme Corporation
- Units Affected
- 27,022 vials
- Distribution
- Nationwide, Puerto Rico and Malaysia, Taiwan, Brazil, and Israel.
- Location
- Cambridge, MA
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Genzyme Corporation. Units affected: 27,022 vials.
Why was this product recalled? ▼
Presence of Particulate Matter: Glass particles found in the product after reconstitution.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on March 9, 2016. Severity: Moderate. Recall number: D-0729-2016.
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