FDA Biologics (BLA & Biosimilars)Original article
Immune Globulin Intravenous (IGIV) Lot with Increased Reports of Allergic/Hypersensitivity Reactions
RegulatoryImmune Globulin IntravenousNegative
AI Analysis
Summary
The FDA's FAERS database has received increased reports of allergic and hypersensitivity reactions associated with a specific lot of Immune Globulin Intravenous (IGIV). This safety signal indicates a potential product quality or manufacturing issue requiring investigation.
Outcome Details
Increased reports of allergic/hypersensitivity reactions following infusion of a specific IGIV lot
Importance:6/10
Sentiment:
-0.70
SafetyAdverse EventsPharmacovigilanceFAERSProduct Safety
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Published by FDA Biologics (BLA & Biosimilars) on October 6, 2026 7:50 PM