Expiration Date Extension for 120 BIVIGAM [Immune Globulin Intravenous (Human), 10% Liquid] Lots manufactured in 2020 - 2022
This is to provide you with important information regarding Immune Globulin Intravenous (Human), 10% Liquid, referred to as BIVIGAM®, which is indicated for the treatment of primary humoral immunodeficiency (PI).
BIVIGAM is manufactured by ADMA Biologics. The FDA has approved an extension of the expiration date for BIVIGAM from 24 to 36 months when stored at +2°C to +8°C (36°F to 46°F). The new expiration date is valid for 120 BIVIGAM lots that were manufactured and distributed in 2020-2022. Future lots will be labeled according to the new dating period.
Please see the list of lots, below, to identify BIVIGAM vials affected by the extended dating period. The lot number is visible on vials and outer carton labels. You may continue to dispense product from the lots below when stored at 2-8oC, until the new expiration date.
| No. | Lot Number | Labeled Expiration Date | New Expiration Date |
|---|---|---|---|
| 1 | 2528-20 | Mar-22 | Mar-23 |
| 2 | 2529-20 | Mar-22 | Mar-23 |
| 3 | 2531-20 | Mar-22 | Mar-23 |
| 4 | 2532-20 | Apr-22 | Apr-23 |
| 5 | 2533-20 | Apr-22 | Apr-23 |
| 6 | 2534-20 | Apr-22 | Apr-23 |
| 7 | 2535-20 | Apr-22 | Apr-23 |
| 8 | 2536-20 | Apr-22 | Apr-23 |
| 9 | 2537-20 | Apr-22 | Apr-23 |
| 10 | 2551-20 | May-22 | May-23 |
| 11 | 2552-20 | May-22 | May-23 |
| 12 | 2553-20 | May-22 | May-23 |
| 13 | 2554-20 | May-22 | May-23 |
| 14 | 2555-20 | May-22 | May-23 |
| 15 | 2556-20 | Jun-22 | Jun-23 |
| 16 | 2557-20 | Jun-22 | Jun-23 |
| 17 | 2558-20 | Jun-22 | Jun-23 |
| 18 | 2559-20 | Jun-22 | Jun-23 |
| 19 | 2560-20 | Jun-22 | Jun-23 |
| 20 | 2579-20 | Jul-22 | Jul-23 |
| 21 | 2580-20 | Jul-22 | Jul-23 |
| 22 | 2581-20 | Jul-22 | Jul-23 |
| 23 | 2582-20 | Jul-22 | Jul-23 |
| 24 | 2583-20 | Aug-22 | Aug-23 |
| 25 | 2584-20 | Aug-22 | Aug-23 |
| 26 | 2585-20 | Aug-22 | Aug-23 |
| 27 | 2586-20 | Aug-22 | Aug-23 |
| 28 | 2587-20 | Sep-22 | Sep-23 |
| 29 | 2588-20 | Sep-22 | Sep-23 |
| 30 | 2594-20 | Sep-22 | Sep-23 |
| 31 | 2595-20 | Oct-22 | Oct-23 |
| 32 | 2623-20 | Oct-22 | Oct-23 |
| 33 | 2624-20 | Oct-22 | Oct-23 |
| 34 | 2625-20 | Nov-22 | Nov-23 |
| 35 | 2626-20 | Nov-22 | Nov-23 |
| 36 | 2627-20 | Nov-22 | Nov-23 |
| 37 | 2628-20 | Nov-22 | Nov-23 |
| 38 | 2629-20 | Nov-22 | Nov-23 |
| 39 | 2630-20 | Nov-22 | Nov-23 |
| 40 | 2631-20 | Dec-22 | Dec-23 |
| 41 | 2632-20 | Dec-22 | Dec-23 |
| 42 | 2633-20 | Dec-22 | Dec-23 |
| 43 | 2634-20 | Dec-22 | Dec-23 |
| 44 | 2635-20 | Dec-22 | Dec-23 |
| 45 | 2636-20 | Dec-22 | Dec-23 |
| 46 | 2658-20 | Jan-23 | Jan-24 |
| 47 | 226909 | Feb-23 | Feb-24 |
| 48 | 2675-21 | Feb-23 | Feb-24 |
| 49 | 227048 | Feb-23 | Feb-24 |
| 50 | 2676-21 | Feb-23 | Feb-24 |
| 51 | 2677-21 | Mar-23 | Mar-24 |
| 52 | 2678-21 | Mar-23 | Mar-24 |
| 53 | 2679-21 | Mar-23 | Mar-24 |
| 54 | 2680-21 | Mar-23 | Mar-24 |
| 55 | 227242 | Mar-23 | Mar-24 |
| 56 | 227243 | Mar-23 | Mar-24 |
| 57 | 227357 | Mar-23 | Mar-24 |
| 58 | 2681-21 | Apr-23 | Apr-24 |
| 59 | 2682-21 | Apr-23 | Apr-24 |
| 60 | 227639 | Apr-23 | Apr-24 |
| 61 | 2683-21 | Apr-23 | Apr-24 |
| 62 | 227640 | Apr-23 | Apr-24 |
| 63 | 2684-21 | Apr-23 | Apr-24 |
| 64 | 227642 | Apr-23 | Apr-24 |
| 65 | 227643 | Apr-23 | Apr-24 |
| 66 | 2703-21 | Apr-23 | Apr-24 |
| 67 | 2704-21 | Apr-23 | Apr-24 |
| 68 | 227645 | Apr-23 | Apr-24 |
| 69 | 227646 | Apr-23 | Apr-24 |
| 70 | 2705-21 | Apr-23 | Apr-24 |
| 71 | 2706-21 | Apr-23 | Apr-24 |
| 72 | 2711-21 | May-23 | May-24 |
| 73 | 2712-21 | May-23 | May-24 |
| 74 | 2713-21 | May-23 | May-24 |
| 75 | 2714-21 | May-23 | May-24 |
| 76 | 2717-21 | May-23 | May-24 |
| 77 | 2718-21 | May-23 | May-24 |
| 78 | 2721-21 | Jun-23 | Jun-24 |
| 79 | 2722-21 | Jun-23 | Jun-24 |
| 80 | 2723-21 | Jun-23 | Jun-24 |
| 81 | 2724-21 | Jun-23 | Jun-24 |
| 82 | 2725-21 | Jun-23 | Jun-24 |
| 83 | 2726-21 | Jun-23 | Jun-24 |
| 84 | 2780-21 | Jul-23 | Jul-24 |
| 85 | 2781-21 | Jul-23 | Jul-24 |
| 86 | 2782-21 | Jul-23 | Jul-24 |
| 87 | 2783-21 | Jul-23 | Jul-24 |
| 88 | 2784-21 | Jul-23 | Jul-24 |
| 89 | 227655 | Jul-23 | Jul-24 |
| 90 | 2785-21 | Jul-23 | Jul-24 |
| 91 | 227647 | Jul-23 | Jul-24 |
| 92 | 228257 | Aug-23 | Aug-24 |
| 93 | 228259 | Sep-23 | Sep-24 |
| 94 | 228260 | Sep-23 | Sep-24 |
| 95 | 228261 | Sep-23 | Sep-24 |
| 96 | 2598-20 | Jul-22 | Jul-23 |
| 97 | 2599-20 | Jul-22 | Jul-23 |
| 98 | 2600-20 | Aug-22 | Aug-23 |
| 99 | 2795-21 | Aug-23 | Aug-24 |
| 100 | 2796-21 | Aug-23 | Aug-24 |
| 101 | 2797-21 | Aug-23 | Aug-24 |
| 102 | 2798-21 | Aug-23 | Aug-24 |
| 103 | 2805-21 | Sep-23 | Sep-24 |
| 104 | 2806-21 | Sep-23 | Sep-24 |
| 105 | 2807-21 | Sep-23 | Sep-24 |
| 106 | 2808-21 | Oct-23 | Oct-24 |
| 107 | 2819-21 | Oct-23 | Oct-24 |
| 108 | 2820-21 | Oct-23 | Oct-24 |
| 109 | 2828-21 | Nov-23 | Nov-24 |
| 110 | 2829-21 | Nov-23 | Nov-24 |
| 111 | 2830-21 | Nov-23 | Nov-24 |
| 112 | 2831-21 | Nov-23 | Nov-24 |
| 113 | 2841-21 | Dec-23 | Dec-24 |
| 114 | 2842-21 | Dec-23 | Dec-24 |
| 115 | 2843-21 | Dec-23 | Dec-24 |
| 116 | 2844-21 | Dec-23 | Dec-24 |
| 117 | 2847-21 | Dec-23 | Dec-24 |
| 118 | 2848-21 | Dec-23 | Dec-24 |
| 119 | 2855-21 | Jan-24 | Jan-25 |
| 120 | 2854-21 | Jan-24 | Jan-25 |