NDC 65219-592
Tyenne 200 mg per 10 mL injection, solution, concentrate
On the label: Fresenius Kabi USA, LLC.
Where it's made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Fresenius Kabi Austria | Austria 8055, Austria | Makes it | Problems found, fixed voluntarilyMar 21, 2024 · 9 inspections |
Recalls
- Aug 10, 2026 · Class I · Fresenius Kabi USA, LLC
Presence of particulate matter:An internal investigation at the firm found the product to contain glass particles.
Lots: Lot: 16UI07, Exp 08/31/2028
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.
Product details
- Generic drug
- Tocilizumab: every company that makes it
- Form
- injection, solution, concentrate, intravenous
- Strength
- 200 mg per 10 mL
- Approval
- BLA BLA761275
- On the market since
- Apr 15, 2024
- Package NDCs
65219-592-10- Official label
- DailyMed (National Library of Medicine), updated May 15, 2026
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