Complement Inhibitor
Where is Eculizumab made?
3 companies sell it under their own name. None of their labels names the factory.
Companies and their factories
| Company on the label | Factory | Where | Last FDA inspection |
|---|---|---|---|
| Alexion Pharmaceuticals Inc. Soliris300 mg per 30 mL · NDC 25682-001 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Amgen Inc Bkemv300 mg per 30 mL · NDC 55513-180 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Teva Pharmaceuticals USA, Inc. Epysqli300 mg per 30 mL · NDC 51759-208 | The label doesn't name the factory. Plants this company names for other drugs | ||
Recalls
- Jun 2, 2014 · Class I · Alexion Pharmaceuticals, Inc.
Presence of Particulate Matter: Product failed the appearance for the presence of visible particles under labeled storage condition. - Nov 4, 2013 · Class I · Alexion Pharmaceuticals, Inc.
Presence of Particulate Matter: Failed the appearance test for the presence of visible particles.
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.