NDC 57894-800
Imaavy 185 mg per 1 mL injection, solution, concentrate
On the label: Janssen Biotech, Inc..
Where it's made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Janssen Biotech, Inc. | Malvern, PA, United States | Makes the active ingredient | Problems found, fixed voluntarilyJul 29, 2025 · 13 inspections |
| Janssen Sciences Ireland UC | CO Cork, Ireland | Makes the active ingredient and tests it | Problems found, fixed voluntarilyJan 12, 2024 · 5 inspections |
| Vetter Pharma Fertigung GmbH & Co. KG (Langenargen Eisenbahnstrasse) | Langenargen, Germany | Makes it and tests it | Problems found, fixed voluntarilyMar 20, 2024 · 8 inspections |
| Vetter Pharma Fertigung GmbH & Co. KG (Ravensburg Mooswiesen) | Ravensburg, Germany | Makes it, tests it and packages it | Problems found, fixed voluntarilyJul 21, 2023 · 8 inspections |
| WuXi Biologics (Shanghai) Co., Ltd. | Shanghai, China | Makes the active ingredient | Not inspected on record |
| WuXi Biologics Co., Ltd. | Wuxi, China | Makes the active ingredient and tests it | Problems found, fixed voluntarilyJul 3, 2026 · 3 inspections |
| Bioreliance Corporation | Rockville, MD, United States | Tests it | Problems found, fixed voluntarilyJan 29, 2026 · 7 inspections |
| Cilag AG | Schaffhausen, Switzerland | Tests it and packages it | No problems foundNov 21, 2025 · 8 inspections |
| Eurofins Biolab Srl | Vimodrone, Italy | Tests it | Problems found, fixed voluntarilySep 13, 2024 · 5 inspections |
| Janssen Biologics B.V. | Leiden, Netherlands | Tests it | Problems found, fixed voluntarilyJun 1, 2023 · 7 inspections |
| Vetter Pharma Fertigung GmbH & Co. KG (Ravensburg Helmut-Vetter-Strasse) | Ravensburg, Germany | Tests it | Problems found, fixed voluntarilyJul 27, 2022 · 6 inspections |
| Vetter Pharma Fertigung GmbH & Co. KG (Ravensburg Schuetzenstrasse) | Ravensburg, Germany | Tests it | Problems found, fixed voluntarilyJul 13, 2022 · 10 inspections |
| WuXi Biologics Biosafety Testing (Suzhou) Co., Ltd. | Suzhou, China | Tests it | Problems found, fixed voluntarilyFeb 2, 2024 · 1 inspection |
Recalls
- Sep 23, 2026 · Class II · J&j Innovative Medicine
Presence of particulate matter.
Lots: Lot JNYJ1208; Exp. 10/30/2027
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.
Product details
- Generic drug
- Nipocalimab: every company that makes it
- Form
- injection, solution, concentrate, intravenous
- Strength
- 185 mg per 1 mL
- Approval
- BLA BLA761430
- On the market since
- Apr 29, 2025
- Package NDCs
57894-800-01- Official label
- DailyMed (National Library of Medicine), updated Aug 21, 2026
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