Bivigam 5g vial lot withdrawn

As a precautionary measure, the following lot of intravenous immune globulin (IVIG) have been voluntarily withdrawn by the manufacturer due to a higher rate of allergic/hypersensitivity type reactions, some of which were considered medically significant.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

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.

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.