Profilnine Recall

Grifols Biologicals Profilnine Recall

on June 15, 2018


On June 14, 2018, the National Hemophilia Foundation issued a Medical Advisory. The Hemophilia of Georgia pharmacies did not distribute any of this product. Medical Advisory #424: Grifols Biologicals has announced a recall of one lot of Profilnine. This recall is being conducted as a precautionary measure. The reason is that the incorrect volume of sterile water for injection was packaged with Profilnine Lot A1PBB00072. Based on the current data available, the manufacturer concludes that there are no serious safety issues identified with this lot. Reconstituting the product with the incorrect volume of sterile water for injection may cause an injection site reaction which is considered low risk. This notice pertains only to the volume of sterile water for injection packaged with this lot. NDA Number: 68516-3208-2 Lot Number: A1PBB00072 Size: 1000iu Expiration Date: 01-31-2020 If you are currently using this lot of Profilnine, please contact your physician or hemophilia treatment center to learn about other options that are available to you for treatment.



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