Medical Device Recalls Reach Five-Quarter High in ExpertRECALL Index
Quarterly Index Highlights Global Element of Medical Device Recalls; Reports Recalls of Undeclared Allergens Remain Greatest Food Safety Threat
INDIANAPOLIS, Aug. 19, 2013 /PRNewswire/ — According to the ExpertRECALL Index released today, 48 percent of all medical device recalls reported in the second quarter of 2013 had both U.S. and international components. In addition, the number of device recalls increased 30 percent from the last quarter, resulting in the highest number of recalls in the last five quarters. With medical device recalls increasing and occurring more frequently on a global scale, manufacturers must be capable of performing a global recall and be knowledgeable of all the regulatory environments within the countries they operate.
“Scalability will be critical for medical device manufacturers facing product recalls going forward, and it’s one of the reasons why ExpertRECALL has recently expanded its global capabilities,” said Rozembajgier. “Safety in global distribution and supply chains has no boundaries. Companies should implement recall plans that prepare for the increased complication and regulatory oversight that they or their vendors will have to navigate during an international product recall.”
Recalls from compounding pharmacies also continue to be a prominent source of pharmaceutical recalls according to the Index. In the second quarter, two compounding pharmacies accounted for 104 recall events, more than 43 percent of all pharmaceutical recalls reported for the quarter. Because of these serious events and the resulting media attention, the FDA has significantly increased its inspections of compounding pharmacies. In addition, the Government Accountability Office (GAO) recently recommended that the FDA be granted greater oversight and regulatory control of compounding pharmacies.
“Compounding pharmacies continue to face multiple events a quarter, which has attracted a lot of regulatory attention. It is more important than ever for these manufacturers to be vigilant and pay close attention to current safety compliance programs and best recall preparedness practices,” Rozembajgier continued. “It is no longer a matter of if the FDA shows up at their door, it is when.”
In the food industry, recalls due to undeclared allergens continue to plague manufacturers. Sixty-five percent of recalls from the United States Department of Agriculture (USDA) in the second quarter of 2013 were the result of an undeclared allergen. The trend is also reflected in recalls by the United States Food and Drug Administration (FDA), with 60 percent of recalls documented on its website occurring due to undeclared allergens, up from 34 percent in the previous quarter. Undeclared allergens have consistently been a top trend for USDA and FDA recalls for the past several quarters.
“Allergens continue to be a top recall trend that we see quarter over quarter,” said Mike Rozembajgier, vice president of Stericycle ExpertRECALL. “Food manufacturers should make sure that they are reviewing labels and formulations related to their company’s Allergen Control Program before an inspector arrives onsite.”
The Consumer Product Safety Commission (CPSC) reported 71 recalls this quarter, the second-lowest number in the past six quarters. However, the CPSC also issued a mandatory recall of a children’s toy product, an action that has only occurred four times in the past 11 years. Because of this, 52 percent of all CPSC recalled units came from one recall in the children’s and infant category.
The 2013 second quarter ExpertRECALL Index is the only report that aggregates and tracks cumulative recall data from the U.S. Consumer Product Safety Commission (CPSC), the FDA and the USDA. The ExpertRECALL Index report is available online at http://www.expertrecall.com/recallindex.
About Stericycle ExpertRECALL(TM)
Stericycle ExpertRECALL(TM) is the global industry leader in managing consumer product, food and beverage, pharmaceutical, medical device and juvenile product 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.
SOURCE Stericycle ExpertRECALL