December 2015 FDA Recall Lumizyme by Genzyme Corporation
D-0799-2016 - Labeling

This Class III drug recall was voluntarily initiated by Genzyme Corporation on December 8, 2015 for the product Lumizyme. The FDA reported the reason for recall as labeling. The product was distributed in TN and the recall is currently terminated.

Recall Number: D-0799-2016

Reason for Recall
Labeling: Incorrect or Missing Lot and/or Exp Date
Initiated
12-08-2015
Reported
04-06-2016
Quantity
24 vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
72929
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.
Genzyme Corporation
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.
E-Mail
Distribution Pattern About Distribution Pattern
General area of initial distribution.
TN
Termination Date About Termination Date
Date that FDA officially terminated the recall.
08-01-2016
Product Description About Product Description
Full technical description of the product.
Lumizyme (alglucosidase alpha), 50 mg/vial, For Intravenous Infusion Only, Rx Only, Manufactured by Genzyme Corportation, Cambridge, MA 02142, NDC 58468-0160-1

Batch or Lot Expiration Information

Lot# C5370C02; Exp. 02/18

Affected Packages Involved in this Recall

58468-0160-1 Lumizyme
58468-0160-2 Lumizyme