Gammagard Liquid FDA Alerts
The FDA Alerts below may be specifically about Gammagard Liquid or relate to a group or class of drugs which include Gammagard Liquid.
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 Gammagard Liquid
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the following lots of Immune Globulin Intravenous (IGIV) and Immune Globulin Subcutaneous (IGSC) have been voluntarily withdrawn by the manufacturers due to a higher rate of allergic/hypersensitivity type reactions, some of which were considered medically significant.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 |
GammaGard Liquid, Immune Globulin Intravenous (Human)
[Posted 06/04/2010]
ISSUE: Baxter BioScience and FDA notified healthcare professionals of a market withdrawal being conducted as a precautionary measure due to an increased number of adverse event reports of allergic reactions associated with two lots of the product.
BACKGROUND: GammaGard Liquid is indicated for the treatment of primary immunodeficiency disorders associated with defects in humoral immunity.
RECOMMENDATION: Customers are asked to contact Baxter BioScience for Urgent Market Withdrawal instructions. See the Market Withdrawal Notice for information on affected lots.
[06/03/2010 - Market Withdrawal Notice - FDA]
