FDA Biologics (BLA & Biosimilars)Original article
Calendar Year 2026 | Voluntary Lot Withdrawals of Immune Globulin Intravenous (IGIV) and Immune Globulin Subcutaneous (IGSC) for Increased Reports of Allergic/Hypersensitivity Reactions
RegulatoryImmune Globulin Intravenous (IGIV)Immune Globulin Subcutaneous (IGSC)Negative
AI Analysis
Summary
Multiple lots of Immune Globulin Intravenous (IGIV) and Immune Globulin Subcutaneous (IGSC) have been voluntarily withdrawn as a precautionary measure due to elevated rates of allergic and hypersensitivity reactions, some of which were medically significant.
Outcome Details
Voluntary lot withdrawals due to increased reports of allergic/hypersensitivity reactions
Importance:6/10
Sentiment:
-0.70
product_safetylot_withdrawaladverse_eventsimmunoglobulinallergic_reactions
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Published by FDA Biologics (BLA & Biosimilars) on October 7, 2026 10:12 PM