Home / Recalls / Genzyme Corporation / D-0799-2016

D-0799-2016 Class III Terminated

Recalled by Genzyme Corporation — Cambridge, MA

Recall Details

Product Type
Drugs
Report Date
April 6, 2016
Initiation Date
December 8, 2015
Termination Date
August 1, 2016
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
24 vials

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

Distribution Pattern

TN

Code Information

Lot # C5370C02; Exp. 02/18

Other recalls by Genzyme Corporation

  • D-0075-2018 Class III — Clolar (clofarabine) 20 mg/20 mL (1 mg/mL) Injection, for intravenous use, Rx O (October 12, 2017)
  • D-0729-2016 Class II — Thyrogen (thyrotropin alfa for injection), 0.9 mg/mL after reconstitution, For i (February 16, 2016)
  • D-0730-2016 Class II — Thyrogen (thyrotropin alfa for injection), 0.9 mg/mL after reconstitution, For i (February 16, 2016)
  • Z-1856-2012 Class II — seprafilm¿ Single Site ADHESION BARRIER Re-order Number: 6641-01 Product Usa (June 13, 2012)
  • Z-1855-2012 Class II — seprafilm¿ Procedure Pack ADHESION BARRIER Re-order Number: 5086-02 Produc (June 13, 2012)