IMAAVY (nipocalimab-aahu) Injection, 300 mg /1.62 mL (185 mg/mL) per single-dose vial, Fo…
Official notice from a government agency or its published feed.
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: Presence of particulate matter.
Class IIA mid-level FDA recall: the product may cause temporary or reversible health problems. · Ongoing · OH
Reason: Presence of particulate matter.
Class IIA mid-level FDA recall: the product may cause temporary or reversible health problems. · Ongoing · OH
Hazard: Presence of particulate matter.
View the FDA enforcement report ↗ ← All reports