This is to provide you with important information regarding Immune Globulin Intravenous, Human-slra, 10% Liquid, referred to as ASCENIV™, which is indicated for the treatment of primary humoral immunodeficiency (PI).
ASCENIV is manufactured by ADMA Biologics. The FDA has approved an extension of the expiration date for ASCENIV 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 6 ASCENIV lots that were manufactured and distributed in 2019-2020. Future lots will be labeled according to the new dating period.
Please see the list of lots, below, to identify ASCENIV 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.
|Lot||Labeled Expiration Date||New Expiration Date|