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  4. Voluntary Lot Withdrawals of Immune Globulin Intravenous (IGIV) and Immune Globulin Subcutaneous (IGSC) for Increased Reports of Allergic/Hypersensitivity Reactions
  1. Safety & Availability (Biologics)

Voluntary Lot Withdrawals of Immune Globulin Intravenous (IGIV) and Immune Globulin Subcutaneous (IGSC) for Increased Reports of Allergic/Hypersensitivity Reactions

March 10, 2025 

As a precautionary measure, the following lots of Immune Globulin Intravenous (IGIV) and Immune Globulin Subcutaneous (IGSC) have been voluntarily withdrawn by the manufacturers due to a higher rate of allergic/hypersensitivity type reactions, some of which were considered medically significant. Hypersensitivity and anaphylactic/anaphylactoid reactions are a known risk with immune globulin products. 

  1. Please examine your stock immediately to determine if you have any vials from these lots. 
  2. If you have product from these lots, please cease use immediately. 
  3. Return the affected product to the point of purchase to receive replacement product. 
Product Lot Date of Voluntary Withdrawal Expiration Date Manufacturer  
Xembify Lot # B01J108133 10-Jan-2025 30-Oct-2027 Grifols 
Xembify Lot # B01J107803 13-Jan-2025 29-Oct-2027 Grifols 
Bivigam Lot # 321524 31-Jan-2025 31-Jul-2027 ADMA Biologics 
Panzyga Lot #L319C8261 12-Feb-2025 14-May-2026 Octapharma 
Gamunex-C Lot #B01J112733 19-Feb-2025 8-Nov-2027 Grifols 
Bivigam Lot # 321724 27-Feb-2025 31-Aug-2027 ADMA Biologics 
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