This is to provide you with important information regarding Rho(D) Immune Globulin (Human), referred to as MICRhoGAM which is indicated for use in preventing Rh immunization.
MICRhoGAM is manufactured by Kedrion Biopharma Inc. FDA has extended the expiration date on this lot of MICRhoGAM, from July 19, 2020, to July 19, 2021. The extension is based upon FDA’s evaluation of stability data, which determined that this lot of product will maintain stability and potency for an additional year.
If you have prefilled syringes of Lot MVP116A1 in your current inventory, labeled with an expiration date of July 19, 2020, you may continue to maintain the product in your inventory and keep it available for use until July 19, 2021.
Future shipments of Lot MVP116A1 will have a sticker on the carton and pouch indicating that the product has a new expiration date of July 19, 2021.