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Device, Pharma Recalls Reach Historic Highs in 2018 First Quarter

Posted in FDA, Life Sciences, Medical Devices, Pharmaceuticals

Medical device and pharmaceutical recalls reached historic highs in the first quarter of 2018, according to a report from Stericyle Expert Solutions.More than 208 million devices were recalled in the quarter, surpassing the number of recalled devices in all of 2017, with software problems accounting for the highest number of recalls. The uptick was due in part to medical device software becoming more complex over the last few years, a trend that is likely to continue. Most other recalls were attributed to mislabeling and general quality issues.

There were 105 pharmaceutical recalls in the quarter, the highest number in almost five years, with failed specifications being the top cause. Other top causes were problems with sterility, mislabeling, foreign materials and subpotency. Over 332 million units were recalled in the quarter, many as part of a single large recall.

Healthcare practitioners need to remain vigilant when prescribing medications and medical devices and must actively monitor recall releases to avoid any potential liabilities.

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