Lumizyme Injection, Powder, For Solution
FDA Recall NDC 58468-0160
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 1 recorded enforcement report(s) associated with Lumizyme (NDC 58468-0160). A significant event, classified as Class III, was initiated on Dec 08, 2015 by Genzyme Corporation. The reported reason for this action was: "Labeling: Incorrect or Missing Lot and/or Exp Date"
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
Reported Recall Events
Class III Terminated
Labeling: Incorrect or Missing Lot and/or Exp Date
Dec 08, 2015
Apr 06, 2016
24 vials
Recall Profile & Regulatory Data
Event ID
72929
Classification
Class III
Enforcement Status
Terminated
Recalling Firm
Genzyme Corporation
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
TN
Termination Date
Aug 01, 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
Batch or Lot Expiration Information
Lot# C5370C02; Exp. 02/18
Affected Packages Involved in this Recall
58468-0160-1Product
58468-0160-2Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
