Bivigam FDA Alerts
The FDA Alerts below may be specifically about Bivigam or relate to a group or class of drugs which include Bivigam.
MedWatch Safety Alerts are distributed by the FDA and published by Drugs.com. Following is a list of possible medication recalls, market withdrawals, alerts and warnings.
Recent FDA Alerts for Bivigam
Voluntary Lot Withdrawals of Immune Globulin Intravenous (IGIV) and Immune Globulin Subcutaneous (IGSC) Due to Increased Reports of Allergic/Hypersensitivity Reactions
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the following lots of Immune Globulin Intravenous (IGIV) and Immune Globulin Subcutaneous (IGSC) have been voluntarily withdrawn by the manufacturers due to a higher rate of allergic/hypersensitivity type reactions, some of which were considered medically significant.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
Voluntary Lot Withdrawals of Immune Globulin Intravenous (IGIV) and Immune Globulin Subcutaneous (IGSC) for Increased Reports of Allergic/Hypersensitivity Reactions
March 4, 2022 -- 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the following lots of Immune Globulin Intravenous (IGIV) and Immune Globulin Subcutaneous (IGSC) have been voluntarily withdrawn by the manufacturers due to a higher rate of allergic/hypersensitivity type reactions, some of which were considered medically significant.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 lot withdrawal | Expiration Date | Manufacturer |
|---|---|---|---|
| Octagam 10% Lot # K139B8541 | 9-Feb-2022 | 3-Oct-2024 | Octapharma |
| Octagam 10% Lot # K140A8561 | 9-Feb-2022 | 9-Oct-2024 | Octapharma |
| Octagam 10% Lot # K139A8561 | 21-Jan-2022 | 1-Oct-2024 | Octapharma |
| Privigen Lot # P100287718 | 10-Jan-2022 | 15-Nov-2023 | CSL Behring |
| Privigen Lot # P100371288 | 10-Jan-2022 | 20-Aug-2024 | CSL Behring |
| Privigen Lot# P100366291 | 10-Jan-2022 | 19-Aug-2024 | CSL Behring |
| Privigen Lot# P100356115 | 30-Dec-2021 | 5-Jul-2024 | CSL Behring |
| Privigen Lot# P100349929 | 19-Oct-2021 | 14-Jun-2024 | CSL Behring |
| Privigen Lot # P100287723 | 6-Oct-2021 | 17-Nov-2023 | CSL Behring |
| Hizentra Lot # P100369103 | 10-Jan-2022 | 18-Feb-2024 | CSL Behring |
| Hizentra Lot # P100369102 | 10-Jan-2022 | 16-Feb-2024 | CSL Behring |
| Hizentra Lot # P100343632 | 30-Dec-2021 | 24-Nov-2023 | CSL Behring |
| Hizentra Lot # P100340460 | 27-Oct-2021 | 12-Nov-2023 | CSL Behring |
| Gamunex-C Lot # A1GLE01642 | 06-Aug-2021 | 6-Dec-2023 | Grifols |
| Gamunex-C Lot # A1GLE01582 | 06-Aug-2021 | 13-Nov-2023 | Grifols |
| Gamunex-C Lot # A4GLE01512 | 06-Aug-2021 | 30-Oct-2023 | Grifols |
| Gamunex-C Lot # A3GLE01432 | 06-Aug-2021 | 10-Oct-2023 | Grifols |
| Gamunex-C Lot # A4GKE01092 | 06-Aug-2021 | 28-Oct-2023 | Grifols |
| Gamunex-C Lot # A4GKE01012 | 06-Aug-2021 | 2-Oct-2023 | Grifols |
| Gamunex-C Lot # A1GKF00042 | 06-Aug-2021 | 23-Jan-2024 | Grifols |
| Gamunex-C Lot # A1GKF00032 | 06-Aug-2021 | 21-Jan-2024 | Grifols |
| Gamunex-C Lot # A1GKF00022 | 06-Aug-2021 | 19-Jan-2024 | Grifols |
| Gamunex-C Lot # A1GKF00052 | 25-Jun-2021 | 25-Jan-2024 | Grifols |
| Gamunex-C Lot # A1GLE01602 | 27-Apr-2021 | 19-Nov-2023 | Grifols |
| Gamunex-C Lot # A3GLE01462 | 23-Mar-2021 | 19-Oct-2023 | Grifols |
| Gamunex-C Lot # A4GLE01482 | 02-Mar-2021 | 22-Oct-2023 | Grifols |
| Gamunex-C Lot # A1GLE01542 | 26-Feb-2021 | 10-Nov-2023 | Grifols |
| Gamunex-C Lot # A1GLE01532 | 26-Feb-2021 | 4-Nov-2023 | Grifols |
Bivigam Immune Globulin Intravenous (Human), 10 Percent Liquid, 100 mL Sterile Vial: Recall - Visible Particles Observed
[Posted 04/05/2013]
ISSUE: During a routine annual reserve inspection, visible particles were observed in lot number 120016 (Expiration Date: March 31, 2014) of Bivigam Immune Globulin Intravenous (Human), 10% Liquid. Biotest is voluntarily recalling this lot from the market. Inspections of other lots of product have not shown the presence of visible particles.
BACKGROUND: Bivigam is indicated for the treatment of patients with primary humoral immunodeficiency (PI).
RECOMMENDATION: Consignees are asked to examine stocks immediately to determine if you have any of Lot 120016 on hand. If so, discontinue distributing the lot and promptly return all vials to Biotest’s Boca Raton, Florida facility.
Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:
- Complete and submit the report Online: www.accessdata.fda.gov/scripts/medwatch/index.cfm
- Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
[04/05/2013 - Recall Notice - FDA]