Where it's made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Genzyme Corporation | Framingham, MA, United States | Makes it and makes the active ingredient | Problems found, fixed voluntarilyApr 9, 2026 · 9 inspections, 1 with FDA action |
| Genzyme Ireland Limited | Waterford, Ireland | Makes it | Problems found, fixed voluntarilyFeb 25, 2022 · 7 inspections |
| Genzyme Corporation | Northborough, MA, United States | Packages it and labels it | No problems foundAug 14, 2025 · 6 inspections |
| Genzyme Corporation | Framingham, MA, United States | Tests it | Problems found, fixed voluntarilyApr 9, 2026 · 9 inspections, 1 with FDA action |
| Genzyme Corporation | Framingham, MA, United States | Tests it | Problems found, fixed voluntarilyApr 9, 2026 · 9 inspections, 1 with FDA action |
Recalls
- Feb 16, 2016 · Class II · Genzyme Corporation
Presence of Particulate Matter: Glass particles found in the product after reconstitution.
Lots: Lot #: E4029Y02 (carton), E4029 (vial) Exp 09/2016 - Feb 16, 2016 · Class II · Genzyme Corporation
Presence of Particulate Matter: Glass particles found in the product after reconstitution.
Lots: Lot #s: E4029Y03, E4029Y04, E4029Y06, E4029Y07, Exp 12/2017
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.
Product details
- Generic drug
- Thyrotropin Alfa: every company that makes it
- Form
- kit
- Strength
- 0.9 mg per 1 mL
- Approval
- BLA BLA020898
- On the market since
- Nov 30, 1998
- Package NDCs
58468-1849-4- Official label
- DailyMed (National Library of Medicine), updated Feb 24, 2023
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