Bivigam, Gamunex-C, and Panzyga lots withdrawn

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the following lots of intravenous immune globulin (IVIG) and subcutaneous immune globulin  (SCIG) have been voluntarily withdrawn by the manufacturers due to a higher rate of allergic/hypersensitivity type reactions, some of which were considered medically significant.

Affected products and lots

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 

Actions

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.