FDA Recall Mozobil
View Recall Number, Date, Reasons, Quantity
FDA Recall Enforcement Reports
The last Recall Enforcement Report for Mozobil with NDC 0024-5862 was initiated on 09-01-2016 as a Class III recall due to labeling: incorrect or missing package insert The latest recall number for this product is D-0704-2017 and the recall is currently terminated as of 02-15-2018 .
| Recall Number | Initiation Date | Report Date | Recall Classification | Product Quantity | Product Description | Status |
|---|---|---|---|---|---|---|
| D-0704-2017 | 09-01-2016 | 05-17-2017 | Class III | 2133 vials | Mozobil (plerixafor injection) 24mg/1.2mL (20mg/mL), For Single Use Only, Rx Only, Manufactured by: Genzyme Corporation 500 Kendall Street, Cambridge, MA 02412 USA NDC: 0024-5862-01 | Terminated |
| D-1518-2016 | 08-04-2016 | 09-28-2016 | Class III | 9,530 vials | Mozobil (plerixafor injection) 24 mg/1.2 mL (20 mg/mL) per vial, Rx Only, For Subcutaneous Injection only, Manufactured by: Genzyme Corporation, 500 Kendall Street, Cambridge, MA 02142 A Sanofi Company Country of Origin : United Kingdom, NDC 0024-5862-01 | Terminated |
What is the Enforcement Report?
All drug recalls are monitored by the Food and Drug Administration (FDA) and are included in the Enforcement Report once they are properly classified. The FDA will determine if a firm's removal or correction actions of a marked product meet the requirements to be considered a "recall". The FDA will also determine the public hazard assessment and a recall classification will be published in the Enforcement Report.