Mozobil Injection, Solution
FDA Recall NDC 0024-5862
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 2 recorded enforcement report(s) associated with Mozobil (NDC 0024-5862). A significant event, classified as Class III, was initiated on Sep 01, 2016 by Sanofi-aventis U.s. Llc. The reported reason for this action was: "Labeling: Incorrect or Missing Package Insert"
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
Reported Recall Events
Class III Terminated
Labeling: Incorrect or Missing Package Insert
Sep 01, 2016
May 17, 2017
2133 vials
Recall Profile & Regulatory Data
Event ID
76896
Classification
Class III
Enforcement Status
Terminated
Recalling Firm
Sanofi-Aventis U.S. LLC
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nattionwide
Termination Date
Feb 15, 2018
Product Description
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
Batch or Lot Expiration Information
Lot# : 5RZ001C, 5RZ001D; Exp. 04/18
Affected Packages Involved in this Recall
0024-5862-01Product
Class III Terminated
Labeling: Incorrect or Missing Lot and/or Exp. Date
Aug 04, 2016
Sep 28, 2016
9,530 vials
Recall Profile & Regulatory Data
Event ID
74968
Classification
Class III
Enforcement Status
Terminated
Recalling Firm
Genzyme Corporation / Genzyme Biosurgery
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
nationwide
Termination Date
Apr 19, 2018
Product Description
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
Batch or Lot Expiration Information
Lot# 5RZ002; Exp. 04/18
Affected Packages Involved in this Recall
0024-5862-01Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
