Safety

Enforcement Reports

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Whereas not all recalls are announced in the media or on our Recalls press release page, all recalls montiored by FDA are included in FDA's weekly Enforcement Report once they are classified according to the level of hazard involved. Users now have five different ways to retrieve FDA's recall information: Product View, Event View, Print-Friendly View, Pending and Download CSV. These views are accessible by selecting links displayed horizontally below the page title and the date of the report. For information about how to navigate the report and for definitions of the report labels, please visit our Enforcement Report Navigation and Definitions page.

FDA is conducting two pilot programs to expedite notifications of Non-Blood (HCT/P, Vaccine, Derivative, etc) product recalls and human drug product recalls to the public. We have created the Human Drug Product Recalls Pending Classification page (also available by selecting the "Pending" report tab) and the Non-Blood Product On-Going Recalls page to provide users with information before the recall has been classified and included in the weekly Enforcement Report Format.

Corrections or changes to recall information previously disclosed in a past Enforcement Report may be necessary for various reasons. For instance, the firm may discover that the initial recall should be expanded to include more batches or lots of the same recalled product than formerly reported. To inform the public of corrections to previous weekly reports, we have created the Changes to Past Enforcement Reports page and will add a note to indicate which Enforcement Reports have been modified. The table posted to the new page supplies information to identify modified recalls, when the recall was initially published to the internet, and the data corrected.

Please continue toe-mail us at webmail@oc.fda.gov with your comments.

 

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Page Last Updated: 12/19/2014
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