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Medical Device Recalls Reach Five-Quarter High in ExpertRECALL Index
Date:8/19/2013

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
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SOURCE Stericycle ExpertRECALL
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