INDIANAPOLIS (PRNewswire) — Food recalls documented by U.S. Food and Drug Administration (FDA) enforcement reports during the fourth quarter of 2012 reached a two year quarterly high, according to the ExpertRECALL™ Index released today. This activity represents an average rate of approximately six food recalls being documented every day in the fourth quarter, affecting some 18.4 million products, more than double the units affected in the previous quarter.
Forty percent of medical device companies named in FDA Enforcement Reports in the final quarter of 2012 were involved in more than one recall. During the same time period, 45 percent of pharmaceutical companies faced more than one recall event – the largest percentage of companies with repeat violations in at least two and a half years. While recalls of medical devices declined when compared to the third quarter of 2012, more than 10 million units were affected. Fourth quarter pharmaceutical recalls also dropped compared to the third quarter, returning to a level more in line with the three previous quarters.
"Right before FDA's announcement of two major requirements proposed under the Food Safety Modernization Act, the agency documented 552 food recalls, representing a 33 percent increase over the previous quarter and reaching the highest level of recall activity in more than two years," said Mike Rozembajgier, vice president of recalls at Stericycle ExpertRECALL. "As the agency continues to shift its focus towards prevention rather than simply reacting to foodborne illness outbreaks, we can expect the FDA to pay more attention to what companies are doing to ensure our food is safe and prevent recalls from occurring. Companies with a recall plan that is ready are likely to best weather the impending storm of increased regulatory scrutiny."
Of the recalled food products announced during the fourth quarter, 94 percent fell within the Class I designation as the units could cause serious health consequences or death. 165 of those recalls were related to issues stemming from a plant processing nut products. Salmonella concerns were the number one cause of food recalls followed by undeclared allergens or other allergen concerns.
"The fourth quarter increase in food recalls is due in large part to the many products affected by a single ingredient supplier, in this case a peanut butter supplier," said Joseph A. Levitt, a Partner in the Hogan Lovells law firm and a former director of FDA's Center for Food Safety and Applied Nutrition, referring to the string of Sunland recalls that started on September 24, 2012. "This also reflects increased vigilance by both food companies and FDA to identify problems before people get sick and recall affected products promptly. Such vigilance will only increase as FDA moves to implement the new Food Safety Modernization Act."
The ExpertRECALL Index also found that recalls within the categories of consumer products and children's and infant products both reached a six-quarter high during the fourth quarter of 2012. While the number of affected consumer product units dropped from over 12 million units reported in the third quarter to just about three million units in the fourth quarter, recalls of sports and recreation products reached the highest level of activity recorded for the category in more than ten quarters. This category includes products like bicycles, snowmobiles and trampolines. In total, consumer product recalls reported during the last quarter of 2012 were responsible for 2,015 product safety incidents, 58 injuries and six deaths.
The 2012 fourth quarter ExpertRECALL Index is the only report that aggregates and tracks cumulative recall data from the U.S. Consumer Product Safety Commission (CPSC) and the FDA. Stericycle ExpertRECALL compiles the ExpertRECALL Index from data issued by FDA and CPSC. The ExpertRECALL Index report is available online at http://www.expertrecall.com/recallindex.
About Stericycle ExpertRECALL™
Stericycle ExpertRECALL™ is the industry leader in managing consumer product, pharmaceutical, medical device, juvenile product, and food and beverage recalls. Stericycle ExpertRECALL streamlines the entire product recall process and manages Notification & Response, Processing & Tracking, and Compliance & Reporting for a variety of companies. For more information, visit http://www.expertrecall.com.