Lumizyme (alglucosidase alpha), 50 mg/vial, For Intravenous Infusion Only, Rx Only, Manufactured ...

FDA Recall #D-0799-2016 — Class III — December 8, 2015

Recall #D-0799-2016 Date: December 8, 2015 Classification: Class III Status: Terminated

Product Description

Lumizyme (alglucosidase alpha), 50 mg/vial, For Intravenous Infusion Only, Rx Only, Manufactured by Genzyme Corportation, Cambridge, MA 02142, NDC 58468-0160-1

Reason for Recall

Labeling: Incorrect or Missing Lot and/or Exp Date

Recalling Firm

Genzyme Corporation — Cambridge, MA

Classification

Class III — Not likely to cause adverse health consequences.

Product Type

Drugs

Product Quantity

24 vials

Distribution

Code Information

Lot # C5370C02; Exp. 02/18

Status

Terminated

Voluntary / Mandated

Voluntary: Firm initiated

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