Interleukin-13 Antagonist
Where is Tralokinumab made?
1 company sell it under their own name. Their labels name 3 factories in the United States and Denmark.
United States 2Denmark 1
Companies and their factories
| Company on the label | Factory | Where | Last FDA inspection |
|---|---|---|---|
| LEO Pharma Inc. Adbry150 mg per 1 mL, 300 mg per 2 mL · NDC 50222-346, 50222-350 | AstraZeneca Pharmaceuticals LPMakes the active ingredient | Frederick, MD, United States | Problems found, fixed voluntarilyJan 2023 |
| Catalent Indiana, LLCMakes it, tests it, packages it and labels it | Bloomington, IN, United States | Serious problems, FDA actionApr 2026 | |
| LEO Pharma A/SMakes it | Ballerup, Denmark | Problems found, fixed voluntarilySep 2024 |
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.
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.