Voluntary Lot Withdrawals of Immune Globulin Intravenous (IGIV) and Immune Globulin Subcutaneous (IGSC) Due to Increased Reports of Allergic/Hypersensitivity Reactions
March 10, 2025
Audience: Patient, Health Professional, Pharmacy, Immunology
March 10, 2025 -- 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the following lots of Immune Globulin Intravenous (IGIV) and Immune Globulin Subcutaneous (IGSC) have been voluntarily withdrawn by the manufacturers due to a higher rate of allergic/hypersensitivity type reactions, some of which were considered medically significant. Hypersensitivity and anaphylactic/anaphylactoid reactions are a known risk with immune globulin products.
- 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.
| 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 |
Source: FDA
More news resources
- FDA Medwatch Drug Alerts
- Daily MedNews
- News for Health Professionals
- New Drug Approvals
- New Drug Applications
- Drug Shortages
- Clinical Trial Results
- Generic Drug Approvals
Subscribe to our newsletter
Whatever your topic of interest, subscribe to our newsletters to get the best of Drugs.com in your inbox.