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  4. Calendar Year 2026 | Voluntary Lot Withdrawals of Immune Globulin Intravenous (IGIV) and Immune Globulin Subcutaneous (IGSC) for Increased Reports of Allergic/Hypersensitivity Reactions
  1. Safety & Availability (Biologics)

Calendar Year 2026 | Voluntary Lot Withdrawals of Immune Globulin Intravenous (IGIV) and Immune Globulin Subcutaneous (IGSC) for Increased Reports of Allergic/Hypersensitivity Reactions

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the following lots of Immune Globulin Intravenous (IGIV) and Immune Globulin Subcutaneous (IGSC) have been voluntarily withdrawn by the manufacturers due to a higher rate of allergic/hypersensitivity type reactions, some of which were considered medically significant.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 LotDate of Voluntary WithdrawalExpiration DateManufacturer
Alyglo Lot # 394C2501830-Jul-202601-May-2028GC Biopharma Corp.
Alyglo Lot # 394C2501930-Jul-202608-May-2028GC Biopharma Corp.
Alyglo Lot # 394C2502030-Jul-202611-May-2028GC Biopharma Corp.
Gammaked Lot # B13K12773311-Aug-202619-Oct-2028Grifols for Kedrion
Gamunex-C Lot # B23L05320311-Aug-202630-Apr-2029Grifols
Yimmugo Lot # C79514513-Aug-202631-Oct-2027Biotest AG
Yimmugo Lot # C79516513-Aug-202630-Sep-2027Biotest AG
Yimmugo lot # C79531407-Oct-202630-Apr-2027Biotest AG
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