CDER Clarifies 170 Percent Increase in Recalls

Recalls for products regulated by the FDA’s Center for Drug Evaluation and Research (CDER) were up 170 percent in fiscal 2007, according to data released by the agency. However, when the recall data are adjusted to account for the incidents leading to specific product corrections, the number of recalls actually declined.

Of the 977 recalls initiated in 2007, 672 resulted from one unidentified repackager, Deborah Autor, director of CDER’s Office of Compliance, said at a recent conference. The result was a massive spike in Class II recalls, with 860 in 2007, compared with 188 during fiscal 2006.

Class II recalls, which are less serious than Class I recalls, represent a product correction where use of or exposure to the drug may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote, the FDA said.

When the recall data is adjusted to account for multiple recall incidents, there were only 306 recalls in 2007, compared with 338 in 2006. There were 14 recalls categorized as Class I, 189 as Class II and 103 as Class III, according to adjusted 2007 data.