August 2016 FDA Recall Mozobil by Genzyme Corporation / Genzyme Biosurgery
D-1518-2016 - Labeling
This Class III drug recall was voluntarily initiated by Genzyme Corporation / Genzyme Biosurgery on August 4, 2016 for the product Mozobil. The FDA reported the reason for recall as labeling. The product was distributed Nationwide and the recall is currently terminated.
Recall Number: D-1518-2016
Labeling: Incorrect or Missing Lot and/or Exp. Date
08-04-2016
09-28-2016
9,530 vials
Recall Profile & Regulatory Data
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.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Genzyme Corporation / Genzyme Biosurgery
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
nationwide
04-19-2018
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
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
