HoG Handbook

Factor Recalls


Sometimes a person with a bleeding disorder will be notified not to use a certain lot number of factor.  He will be told how to return it.  The factor has been "recalled."  A recall means that either the government or the maker of the factor is concerned that there may be something wrong with it.

The U.S. Food and Drug Administration Center for Biologics Evaluation and Research (FDA CBER) is the government agency responsible for ensuring the safety and efficacy of factor concentrates and other blood products.

The agency's website lists all of the recalls and market withdrawals of fractionated blood and plasma products.  The website also allows you to sign up to receive an e-mail notice of all recalls and market withdrawals of factor.