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 |