PlainRecalls
FDA Drug Low Class III Terminated

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

Reported: April 6, 2016 Initiated: December 8, 2015 #D-0799-2016

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

Details

Recalling Firm
Genzyme Corporation
Units Affected
24 vials
Distribution
TN
Location
Cambridge, MA

Frequently Asked Questions

What product was recalled?
Lumizyme (alglucosidase alpha), 50 mg/vial, For Intravenous Infusion Only, Rx Only, Manufactured by Genzyme Corportation, Cambridge, MA 02142, NDC 58468-0160-1. Recalled by Genzyme Corporation. Units affected: 24 vials.
Why was this product recalled?
Labeling: Incorrect or Missing Lot and/or Exp Date
Which agency issued this recall?
This recall was issued by the FDA Drug on April 6, 2016. Severity: Low. Recall number: D-0799-2016.