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Grifols Biologicals is initiating a voluntary product recall of one lot of Profilnine. Grifols Biologicals has determined there is low risk to the patient associated with this issue; however, Grifols Biologicals is requesting the lot to be returned out of caution.

Therapy
Plasma Product
NDC Number Lot Number Size Packaging Expiration Date
68516-3208-2 A1PBB00072 1000 IU Profilnine 01-31-2020
Reason This recall is being conducted as a precautionary measure.

An 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.

Action 1) Please check all product labels against the affected lot number.
2) Do not take this product. Contact Grifols Customer Service for return instructions and replacement product.
3) Contact your physician if you have medical questions.
Other Information If you need assistance, please call Grifols Customer Service 888-325-8579
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