FDAClass IIIApril 6, 2016

Lumizyme recall: Labeling Error

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

Why was Lumizyme recalled?

Labeling: Incorrect or Missing Lot and/or Exp Date

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lot # C5370C02; Exp. 02/18

Product
Lumizyme (alglucosidase alpha), 50 mg/vial, For Intravenous Infusion Only, Rx Only, Manufactured by Genzyme Corportation, Cambridge, MA 02142, NDC…
Recalling firm
Genzyme Corporation
Quantity
24 vials
Distribution
TN
Recall date
April 6, 2016
Classification
Class III
Status
Terminated
Agency
FDA (drug)
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