Dictionary: Using the recall process, manufacturers may voluntarily remove a drug from the marketplace if a drug quality defect is found. The Office of Compliance (OC) classifies the recall (or recommends classification in some cases) based on the level of public health risk. A Class I recall is the most significant recall. A recall may be done for a single product dosage form or for multiple dosage forms, or multiple products, therefore we report both the number of recall events and the number of products recalled.
These measures have been retired as CDER has created new measures for FY13 which align to their four functional areas of 1) Regulatory Review and Drug Safety, 2) Drug Quality and Compliance, 3) Transparency and Public Outreach, and 4) Regulatory Science Research.
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.