Bivigam, Gamunex-C and Panzyga Lots Withdrawn

Specific lots of intravenous immune globulin (IVIG) and subcutaneous IG  (SCIG) have been voluntarily withdrawn by the manufacturers due to a higher rate of allergic/hypersensitivity type reactions, some of which were considered medically significant.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

• 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 IG products.

Contact: For technical or clinical questions, contact ADMA Customer Service at Customerservice@ADMAbio.com or call (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 IG products. This withdrawal is being conducted with the knowledge of the U.S. Food and Drug Administration, Center for Biologics Evaluation and Research.

Contact: For 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 

Examine your stock immediately to determine if you have any vials from these lots. If you have product from these lots, cease use immediately and return the affected product to the point of purchase to receive replacement product.