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  4. Expiration Date Extension for 120 BIVIGAM [Immune Globulin Intravenous (Human), 10% Liquid] Lots manufactured in 2020 - 2022
  1. Safety & Availability (Biologics)

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

 

 
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