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the following lots of Immune Globulin Intravenous (IGIV) and Immune Globulin Subcutaneous (IGSC) have been voluntarily withdrawn by the manufacturers due to a higher rate of allergic/hypersensitivity type reactions, some of which were considered medically significant.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 |