NDC 58468-0160
Lumizyme 5 mg per 1 mL injection, powder, for solution
On the label: Genzyme Corporation.
Where it's made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Genzyme Flanders | Geel, Belgium | Makes it, makes the active ingredient and tests it | Problems found, fixed voluntarilySep 25, 2024 · 9 inspections |
| Genzyme Ireland Limited | Waterford, Ireland | Makes it, tests it, packages it and labels it | Problems found, fixed voluntarilyFeb 25, 2022 · 7 inspections |
| Eurofins Biopharma Product Testing Ireland Limited | Ireland | Tests it | Problems found, fixed voluntarilyMay 26, 2023 · 5 inspections |
| Genzyme Corporation | Northborough, MA, United States | Packages it and labels it | No problems foundAug 14, 2025 · 6 inspections |
Recalls
- Dec 8, 2015 · Class III · Genzyme Corporation
Labeling: Incorrect or Missing Lot and/or Exp Date
Lots: Lot # C5370C02; Exp. 02/18
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.
Product details
- Generic drug
- Alglucosidase Alfa: every company that makes it
- Form
- injection, powder, for solution, intravenous
- Strength
- 5 mg per 1 mL
- Approval
- BLA BLA125291
- On the market since
- May 24, 2010
- Package NDCs
58468-0160-158468-0160-2- Official label
- DailyMed (National Library of Medicine), updated Jan 10, 2025
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