Prescription drug
Where is Rasburicase made?
1 company sell it under their own name. Their labels name 2 factories in Italy and France.
Italy 1France 1
Companies and their factories
| Company on the label | Factory | Where | Last FDA inspection |
|---|---|---|---|
| Sanofi-Aventis U.S. LLC Elitek1.5 mg per 1 mL, 7.5 mg per 5 mL · NDC 0024-5150, 0024-5151 | Sanofi S.r.l.Makes it, tests it, packages it and labels it | Anagni, Italy | Problems found, fixed voluntarilyOct 2024 |
| Sanofi Winthrop IndustrieMakes the active ingredient and tests it | Aramon, France | Problems found, fixed voluntarilyMar 2023 |
Recalls
- Aug 10, 2020 · Class II · Sanofi-Aventis U.S. LLC
Failed Stability Specifications: Out of Specification result for enzyme activity levels noted during routine stability testing.
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.