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the following lots of Immune Globulin Intravenous (IGIV) and Immune Globulin Subcutaneous (IGSC) have been voluntarily withdrawn by the manufacturers due to a higher rate of allergic/hypersensitivity type reactions, some of which were considered medically significant.
|
Product Lot |
Date of Voluntary Withdrawal |
Expiration Date |
Manufacturer |
|
Xembify Lot # B01J108133 |
10-Jan-2025 |
30-Oct-2027 |
Grifols |
|
Xembify Lot # B01J107803 |
13-Jan-2025 |
29-Oct-2027 |
Grifols |
|
Bivigam Lot # 321524 |
31-Jan-2025 |
31-Jul-2027 |
ADMA Biologics |
|
Panzyga Lot #L319C8261 |
12-Feb-2025 |
14-May-2026 |
Octapharma |
|
Gamunex-C Lot #B01J112733 |
19-Feb-2025 |
8-Nov-2027 |
Grifols |
|
Bivigam Lot # 321724 |
27-Feb-2025 |
31-Aug-2027 |
ADMA Biologics |
BACKGROUND: Hypersensitivity and anaphylactic/anaphylactoid reactions are a known risk with immune globulin products.
RECOMMENDATIONS:
-
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.
[3/10/2025 – FDA Safety Communication]
-
Content current as of:
03/11/2025
