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Notification - URGENT: Voluntary Market Withdrawal


June 14, 2018

Notification - URGENT Voluntary Market Withdrawal

Initiated by : Grifols Biologicals
Event Id :  171
Event Date :  06-14-2018
Therapy
Plasma Product – Profilnine
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.

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