Recall D-0016-2027

US Class II Ongoing · initiated 2026-09-23

Recalling firm

J&J INNOVATIVE MEDICINE, PA

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 for recall

Presence of particulate matter.

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