FDARecalled Oct 14, 2026 · #D-0016-2027
IMAAVY (nipocalimab-aahu) Injection, 300 mg /1.62 mL (185 mg/mL) per single-dose vial, For Intravenous Infusion After Dilution, Rx only, Manufactured by: Janssen Biotech, Inc., Horsham, PA 19044. ...
Hazard
Class II — temporary health risk
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Presence of particulate matter. Classification: Class II Distribution: OH
Product details
- Product
- IMAAVY (nipocalimab-aahu) Injection, 300 mg /1.62 mL (185 mg/mL) per single-dose vial, For Intravenous Infusion After Dilution, Rx only, Manufactured by: Janssen Biotech, Inc., Horsham, PA 19044. NDC: 57894-800-01
- Type
- Drugs
- Manufacturer
- J&J INNOVATIVE MEDICINE
- Model numbers
- JNYJ1208
- UPCs
- —