Drug recall
Thyrogen (thyrotropin alfa for injection), 0.9 mg/mL after reconstitution, For intramuscular injection only…
FDA recall event 73301 · Class II · Genzyme Corporation
Key facts
| Event ID | 73301 |
|---|---|
| Recall numbers | D-0729-2016, D-0730-2016 |
| Recalling firm | Genzyme Corporation |
| Product type | Drugs |
| Products | 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…, 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… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Presence of Particulate Matter: Glass particles found in the product after reconstitution. |
| Initiation date | Feb 16, 2016 |
| Report date | Mar 9, 2016 |
| Termination date | Mar 2, 2017 |
| City | Cambridge |
| State | MA |
| Country | United States |
| FEI number | 1221955 |
At a glance
- 1–9 Products in this recall
- 10–99 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: