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Medicine / D-0016-2027

U.S. Food and Drug AdministrationD-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:…

Class II Ohio named in distribution Status: Ongoing

What was recalled

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

Recalling firm

J&J INNOVATIVE MEDICINE

Reason for recall

Presence of particulate matter.

Where it went

OH

Shown as U.S. Food and Drug Administration published it (shortened where marked …). Recall Shelf does not change recall facts and is not affiliated with the agency.