Where it's made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| AstraZeneca Pharmaceuticals LP | Frederick, MD, United States | Makes the active ingredient | Problems found, fixed voluntarilyJan 19, 2023 · 5 inspections |
| Catalent Indiana, LLC | Bloomington, IN, United States | Makes it, tests it, packages it and labels it | Serious problems, FDA actionApr 24, 2026 · 10 inspections, 2 with FDA action |
| LEO Pharma A/S | Ballerup, Denmark | Makes it | Problems found, fixed voluntarilySep 26, 2024 · 6 inspections, 1 with FDA action |
Recalls
- Feb 10, 2026 · Class II · Leo Pharma Inc
Lack of Assurance of Sterility: due to the presence of particulate matter in one unit from the lot, which lab tests have identified as wool fiber.
Lots: Lot: a) 003E24C, Exp 04/30/2027; b) 003E24A, Exp 04/30/2027.
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.
Product details
- Generic drug
- Tralokinumab: every company that makes it
- Form
- injection, solution, subcutaneous
- Strength
- 300 mg per 2 mL
- Approval
- BLA BLA761180
- On the market since
- Jul 1, 2024
- Package NDCs
50222-350-0050222-350-0150222-350-0250222-350-9050222-350-91- Official label
- DailyMed (National Library of Medicine), updated Dec 17, 2025
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