FDA-TRACK Update: Check out CDER's timely recall classification


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Learn More: CDER's Drug Recall Classification

A recall is an action taken by a firm to remove product(s) from the market. It may be conducted by a firm's own initiative, by FDA request, or by FDA order under statutory authority. FDA classifies recalls based on the level of health risk of the product, with a Class I recall being the most serious in which the product may cause serious adverse health consequence. The Center for Drug Evaluation and Research (CDER) has a performance measure in FDA-TRACK to track and improve its recall classification timeliness.

In late 2013, CDER's target to recommend and classify drug recalls to Class I within the designated timeframe was increased from 85% to 90% because the Center has placed a higher priority on classifying very serious health consequence recalls compared to recalls that involve less serious consequences.  The trend in achieving this 90% target has been steady – in fact, the Center has been hitting 100% for about a year. To continue tracking this progress, visit the FDA-TRACK CDER Dashboard.


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