In July 2011, FDA began a pilot program to notify people of drug recalls before they are classified in an effort to expedite notifications of human drug product recalls to the public. FDA is now able to accomplish the goal of expedited notification within the Enforcement Report. These recalls are identified within the Enforcement Report by the label of “Not Yet Classified” in the “Classification” column. It is also possible to search the Enforcement Report for these “Not Yet Classified” recalls using the filter drop down menu. Therefore, as of September 15, 2017 FDA will discontinue the pilot program, and will no longer post drug recalls that are pending classification on this webpage. To see posted recalls that are pending classification go to the weekly Enforcement Report.
Phenytoin is an antiepileptic drug which can be useful in the treatment of epilepsy. The primary site of action appears to be the motor cortex where spread of seizure activity is inhibited. Phenytoin reduces the maximal activity of brain stem centers responsible for the tonic phase of tonic-clonic (grand mal) seizures. Phenytoin acts to dampen the unwanted, runaway brain activity seen in seizure by reducing electrical conductance among brain cells. It lacks the sedation effects associated with phenobarbital. There are some indications that phenytoin has other effects, including anxiety control and mood stabilization, although it has never been approved for those purposes by the FDA. Phenytoin is primarily metabolized by CYP2C9.