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U.S. Department of Health and Human Services

About FDA

Number of warning letters issued for unapproved drugs that are not part of class actions

Dictionary: The Unapproved Drugs initiative is described in detail on FDA Internet. In removing unapproved drugs from the marketplace, OC may issue a class action to all manufacturers and/or individual actions to individual manufacturers. For the initial version of this measure we are reporting on class actions, as well as other actions such as seizures or injunctions.

Information is current as of December 31, 2013.

Fiscal Year - 2013

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Oct - Dec 2012N/A0
Jan - Mar 2013N/A4
Apr- Jun 2013N/A0
July- Sept 2013N/A0

FY 2013 Total: 4


  • CDER created new measures and began collecting data in July 2012. Therefore, FY12 will only include 3 months of data.


Note: The data provided on this website is produced on an ongoing basis for performance management purposes and is subject to change due to updates of preliminary estimates, corrections, or other reasons. In addition, FDA may change the type or amount of data provided on this website at any time. Information marked as "Completed" may include measures and/or key projects for which activities are ongoing but no longer tracked as part of FDA-TRACK.