Understanding primary immunodeficiency (PI)
Understanding PI
The more you understand about primary immunodeficiency (PI), the better you can live with the disease or support others in your life with PI. Learn more about PI, including the various diagnoses and treatment options.
Learn more about PI
Living with PI
Living with PI
Living with primary immunodeficiency (PI) can be challenging, but you’re not alone—many people with PI lead full and active lives. With the right support and resources, you can, too.
Learn more about living with PI
Get involved
Get involved
Be a hero for those with PI. Change lives by promoting primary immunodeficiency (PI) awareness and taking action in your community through advocacy, donating, volunteering, or fundraising.
Get involved today
Advancing research and clinical care
Advancing research and clinical care
Whether you’re a clinician, researcher, or an individual with primary immunodeficiency (PI), IDF has resources to help you advance the field. Get details on surveys, grants, and clinical trials.
View resource details

Gamunex-C lot withdrawn

March 28, 2025

As a precautionary measure, the following lot of intravenous immune globulin (IVIG) have been voluntarily withdrawn by the manufacturer due to a higher rate of allergic/hypersensitivity type reactions, some of which were considered medically significant.

Affected products and lots

Gamunex®-C

NDC number: 13533-800-40
Lot number(s): B23K001433
Size: 40 g
Packaging: 400 ml vial
Expiration date(s): 12-18-2027
Reason: This voluntary withdrawal is being conducted as a precautionary measure due to an increased rate of allergic/hypersensitivity type reactions associated with this specific lot. A small number of the reactions were considered medically significant. Hypersensitivity and anaphylactic/anaphylactoid reactions are a known risk with immune globulin products. This withdrawal is being conducted with the knowledge of the U.S. Food and Drug Administration, Center for Biologics Evaluation and Research.
Contact: If you have any technical or clinical questions, please contact US Clinical Communications at (800) 520-2807

Actions:

Please examine your stock immediately to determine if you have any vials from these lots.
If you have product from these lots, please cease use immediately.
Return the affected product to the point of purchase to receive replacement product.

Previous notices

March 21, 2025 | Bivigam 5g vial lot withdrawn

Affected products and lots

Bivigam

NDC number: 69800-6502-1
Lot number(s): 237447
Size: 5g
Packaging: 50 ml vial
Expiration date(s): 06-30-2027
Reason: This voluntary withdrawal is being conducted due to the potential for an increased rate of allergic hypersensitivity type reactions associated with this specific lot. Hypersensitivity and anaphylactic/anaphylactoid reactions are a known risk with immune globulin products.
Contact: If you have any technical or clinical questions, please contact ADMA Customer Service at Customerservice@ADMAbio.com or call 1-888-458-4244.

March 11, 2025 | Bivigam, Gamunex-C, Panzyga lots withdrawn

Bivigam

NDC number: 69800-6503-1
Lot number(s): 321524 and 321724
Size: 10g
Packaging: 100 ml vial
Expiration date(s):07-01-2027 and 08-31-2027
Reason: This voluntary withdrawal is being conducted due to the potential for an increased rate of allergic/hypersensitivity type reactions associated with this specific lot. Hypersensitivity and anaphylactic/anaphylactoid reactions are a known risk with immune globulin products.
Contact: If you have any technical or clinical questions, please contact ADMA Customer Service at Customerservice@ADMAbio.com or call 1-888-458-4244.

Gamunex-C

NDC number: 13533-800-40
Lot number(s): B01J112733
Size: 40g
Packaging: 400mL vial
Expiration date(s): 11-08-2027
Reason: This voluntary withdrawal is being conducted as a precautionary measure due to an increased rate of allergic/hypersensitivity type reactions associated with this specific lot. A small number of the reactions were considered medically significant. Hypersensitivity and anaphylactic/anaphylactoid reactions are a known risk with immune globulin products. This withdrawal is being conducted with the knowledge of the U.S. Food and Drug Administration, Center for Biologics Evaluation and Research.
Contact: If you have technical or clinical questions, please contact U.S. Clinical Communications at (800) 520-2807.

Panzyga

Lot number(s): L319C8261
Expiration date(s): 05-14-2026

January 24, 2025 | Xembify lots withdrawn

Grifols Therapeutics is initiating a voluntary withdrawal of two lots of XEMBIFY, 20% 4G VIAL.

Xembify

NDC Number: 13533-810-20
Lot Numbers: B01J107803, B01J108133
Size: 4g
Packaging: 20 mL
Expiration Dates: 10-29-2027, 10-30-2027

Reason

This is to inform you that Grifols Therapeutics is initiating a voluntary withdrawal of one lot of XEMBIFY, 20% 4G VIAL as detailed below.

Grifols is committed to providing the highest quality medicines in the market. This voluntary withdrawal is being conducted due to the potential for an increased rate of allergic/hypersensitivity type reactions associated with this specific lot. Although Grifols has not received any reports of allergic/hypersensitivity type reactions related to this lot as of January 13, 2025, it is being withdrawn as a precautionary measure following an increased rate of reported hypersensitivity reactions in a separate lot made from the same source material. Hypersensitivity and anaphylactic/anaphylactoid reactions are a known risk with immune globulin products.

Other Information

If you have any technical or clinical questions, please contact US Clinical Communications at (800) 520-2807.

Topics

Plasma & Ig therapy

Immune Deficiency Foundation
7550 Teague Road, Suite 220
Hanover, Maryland 21076

P: 410-321-6647

; (function (win) { win.egProps = { campaigns: [ { campaignId: '649545', customDomain: 'give.primaryimmune.org', donation: { modal: { lazyLoad: true, urlParams: { egrn: true }, elementSelector: 'SELECTOR FROM YOUR WEBSITE' }, nudgeTrays: [ // CUSTOMIZE YOUR MESSAGE { title: 'Make a difference', content: 'Complete your gift to help make our mission possible.', ctaLabel: 'Give Now', ctaColor: '#0067b1', triggerEvent: 'eg:donation:incomplete', }, ], } } ] } win.document.body.appendChild(makeEGScript()) /* Create the embed script */ function makeEGScript() { var egScript = win.document.createElement('script') egScript.setAttribute('type', 'text/javascript') egScript.setAttribute('async', 'true') egScript.setAttribute('src', 'https://sdk.classy.org/embedded-giving.js') return egScript } /* Read URL Params from your website. This could potentially * be included in the embed snippet */ function readURLParams() { const searchParams = new URLSearchParams(location.search) const validUrlParams = ['c_src', 'c_src2'] return validUrlParams.reduce(function toURLParamsMap(urlParamsSoFar, validKey) { const value = searchParams.get(validKey) return value === null ? urlParamsSoFar : { ...urlParamsSoFar, [validKey]: value } }, {}) } })(window)

Gamunex-C lot withdrawn