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Medical Device Recalls Reach Five-Quarter High

FDA increases inspections of compounding pharmacies

Stericycle Inc.
Tue, 08/27/2013 - 11:44
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According to the quarterly ExpertRECALL Index, 48 percent of all medical device recalls reported during 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.

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“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,” says Mike Rozembajgier, vice president of Stericycle ExpertRECALL. “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.”

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