Hydrolytic Lysosomal Glycogen-specific Enzyme
Where is Alglucosidase Alfa made?
1 company sell it under their own name. Their labels name 2 factories in Belgium and Ireland.
Belgium 1Ireland 1
Companies and their factories
| Company on the label | Factory | Where | Last FDA inspection |
|---|---|---|---|
| Genzyme Corporation Lumizyme5 mg per 1 mL · NDC 58468-0160 | Genzyme FlandersMakes it, makes the active ingredient and tests it | Geel, Belgium | Problems found, fixed voluntarilySep 2024 |
| Genzyme Ireland LimitedMakes it, tests it, packages it and labels it | Waterford, Ireland | Problems found, fixed voluntarilyFeb 2022 |
Recalls
- Dec 8, 2015 · Class III · Genzyme Corporation
Labeling: Incorrect or Missing Lot and/or Exp Date
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.