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
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.
PHYSICIANS: Please distribute this information to all providers in your area who treat patients with hemophilia.
CHAPTERS: Please distribute this information to your membership.
Please sign up for the Patient Notification System (PNS) to be notified directly about the latest recall or withdrawal of recombinant and plasma products. The system is confidential and time sensitive. It is administered by an independent third-party organization and is free of charge. To enroll in the PNS, please call (888) UPDATE-U or go online at http://www.patientnotificationsystem.org
This material is provided for your general information only. NHF does not give medical advice or engage in the practice of medicine. NHF under no circumstances recommends treatment for specific individuals and in all cases recommends that you consult your physician or local hemophilia treatment center before pursuing any course of treatment.