September 2016 FDA Recall Mozobil by Sanofi-aventis U.s. Llc
D-0704-2017 - Labeling

This Class III drug recall was voluntarily initiated by Sanofi-aventis U.s. Llc on September 1, 2016 for the product Mozobil. The FDA reported the reason for recall as labeling. The product was distributed in Nattionwide and the recall is currently terminated.

Recall Number: D-0704-2017

Reason for Recall
Labeling: Incorrect or Missing Package Insert
Initiated
09-01-2016
Reported
05-17-2017
Quantity
2133 vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
76896
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Sanofi-Aventis U.S. LLC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nattionwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-15-2018
Product Description About Product Description
Full technical description of the product.
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

0024-5862-01 Mozobil