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TOPIC: Immune Globulin Intravenous (IGIV) and Immune Globulin Subcutaneous (IGSC): Voluntary Lot Withdrawals - Due to Increased Reports of Allergic/Hypersensitivity Reactions
AUDIENCE: Patient, Health Professional, Pharmacy, Immunology
ISSUE: 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the following lots of Immune Globulin Intravenous (IGIV) and Immune Globulin Subcutaneous (IGSC) have been voluntarily withdrawn by the manufacturers due to a higher rate of allergic/hypersensitivity type reactions, some of which were considered medically significant.
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Product Lot
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Date of Voluntary Withdrawal
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Expiration Date
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Manufacturer
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Xembify Lot # B01J108133
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10-Jan-2025
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30-Oct-2027
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Grifols
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Xembify Lot # B01J107803
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13-Jan-2025
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29-Oct-2027
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Grifols
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Bivigam Lot # 321524
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31-Jan-2025
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31-Jul-2027
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ADMA Biologics
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Panzyga Lot #L319C8261
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12-Feb-2025
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14-May-2026
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Octapharma
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Gamunex-C Lot #B01J112733
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19-Feb-2025
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8-Nov-2027
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Grifols
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Bivigam Lot # 321724
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27-Feb-2025
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31-Aug-2027
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ADMA Biologics
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For more information about this alert, click on the red button "Read Alert" below.
BACKGROUND: Hypersensitivity and anaphylactic/anaphylactoid reactions are a known risk with immune globulin products.
RECOMMENDATIONS:
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Please examine your stock immediately to determine if you have any vials from these lots.
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If you have product from these lots, please cease use immediately.
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Return the affected product to the point of purchase to receive replacement product.
[3/10/2025 - FDA Safety Communication]
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Health care professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:
- Complete and submit the report online.
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Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on form, or submit by fax to 1-800-FDA-0178.
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