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  4. Expiration Date Extension for 43 Cutaquig [Immune globulin, Subcutaneous (Human)-hipp, 16.5% Solution] Lots manufactured in 2019 and 2020
  1. Safety & Availability (Biologics)

Expiration Date Extension for 43 Cutaquig [Immune globulin, Subcutaneous (Human)-hipp, 16.5% Solution] Lots manufactured in 2019 and 2020

This is to provide you with important information regarding Immune globulin, Subcutaneous (Human)-hipp, 16.5% Solution, referred to as Cutaquig, which is indicated for the treatment of Primary Immune Deficiency.

Cutaquig is manufactured by Octapharma Pharmazeutika Produktionsges.m.b.H. The FDA has approved an extension of the expiration date for Cutaquig 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 43 Cutaquig lots that were manufactured and distributed in 2019-2020. Future lots will be labeled according to the new dating period. The 6-month shelf life for Cutaquig stored at room temperature up to +25°C (77°F) is unchanged.

Please see the list of lots, below, to identify Cutaquig 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. Please note that the expiration date extension does not apply to Cutaquig lots that have already been stored at 25oC.

No. Lot number Labeled expiration date New expiration date
1 K003A8142 14-Jan-22 14-Jan-23
2 K003B8144 15-Jan-22 15-Jan-23
3 K003E8142 17-Jan-22 17-Jan-23
4 K014A8141 02-Apr-22 02-Apr-23
5 K909A8141 27-Feb-21 27-Feb-22
6 K909B8141 27-Feb-21 27-Feb-22
7 K909C8141 28-Feb-21 28-Feb-22
8 K909D8141 28-Feb-21 28-Feb-22
9 K913A8141 29-Mar-21 29-Mar-22
10 K913B8141 29-Mar-21 29-Mar-22
11 K915A8141 10-Apr-21 10-Apr-22
12 K915B8141 10-Apr-21 10-Apr-22
13 K916A8141 16-Apr-21 16-Apr-22
14 K916B8141 16-Apr-21 16-Apr-22
15 K919B8141 08-May-21 08-May-22
16 K919C8141 08-May-21 08-May-22
17 K919C8143 08-May-21 08-May-22
18 K921A8141 20-May-21 20-May-22
19 K921B8141 22-May-21 22-May-22
20 K921C8141 22-May-21 22-May-22
21 K926A8141 24-Jun-21 24-Jun-22
22 K926B8141 25-Jun-21 25-Jun-22
23 K936A8142 03-Sep-21 03-Sep-22
24 K936C8145 06-Sep-21 06-Sep-22
25 K937A8145 09-Sep-21 09-Sep-22
26 K937B8144 09-Sep-21 09-Sep-22
27 K939C8141 29-Sep-21 29-Sep-22
28 K939D8141 29-Sep-21 29-Sep-22
29 K940A8141 01-Oct-21 01-Oct-22
30 K940B8141 01-Oct-21 01-Oct-22
31 K940C8141 05-Oct-21 05-Oct-22
32 K942A8141 16-Oct-21 16-Oct-22
33 K942B8141 17-Oct-21 17-Oct-22
34 K943A8141 25-Oct-21 25-Oct-22
35 K947A8141 19-Nov-21 19-Nov-22
36 K947C8141 21-Nov-21 21-Nov-22
37 K948B8141 01-Dec-21 01-Dec-22
38 K948C8141 01-Dec-21 01-Dec-22
39 K948D8141 29-Nov-21 29-Nov-22
40 K950A8141 11-Dec-21 11-Dec-22
41 K950B8141 11-Dec-21 11-Dec-22
42 K952A8143 24-Dec-21 24-Dec-22
43 K014B8141 02-Apr-22 02-Apr-23
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