J&J INNOVATIVE MEDICINE: IMAAVY (nipocalimab-aahu) Injection, 300 mg /1.62 mL (185 mg/mL) per single-dose vial, For Intravenous Infusion After Dilution, Rx only, Man
Read the official notice at FDA (drug) →
The text below is copied from the official FDA (drug) record. If anything differs, the official notice is correct.
- Company / brand
- J&J INNOVATIVE MEDICINE
- 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
- Reason / hazard
- Presence of particulate matter.
- Classification
- Class II
- Status
- Ongoing
- Distribution / sold at
- OH
- Recall initiated
- 2026-09-23
- Code info
- Lot JNYJ1208; Exp. 10/30/2027
- Product quantity
- 49 vials
- Voluntary mandated
- Voluntary: Firm initiated
- City
- Malvern
- State
- PA
- Country
- United States
- Event id
- 99972
Free daily digest + "My products" watchlist