In the third quarter of 2018, faulty manufacturing practices had an impact on the pharmaceutical industry, according to the latest Recall Index released November 13 by Stericycle Expert Solutions.
Drug recalls increased 19 percent to 92, though recalled units declined 56 percent to just over 7 million; lower than 10 of the last 13 quarters.
Failed specifications were the top reason based on recalls for the ninth consecutive quarter. At 36.9 percent, deviations from current Good Manufacturing Practice (cGMP) regulations were the top cause based on units for the third consecutive quarter. Less serious FDA Class II and Class III recalls comprised nearly all pharmaceutical recalled units during the quarter, with just 1.9 percent being more health threatening Class I recalled units.
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Medical Device Increasing Complexit
Production problems affected the medical device industry as well in Q3. Medical device recalls decreased 21 percent to 284. Recalled units decreased 31 percent to around 29.4 million; the lowest since Q1 2017.
At 48.1 percent, machine failure was the top cause of recalls based on units for the first time since Q1 2016, mainly due to one large recall. Software issues were the top cause (21.8 percent) of overall recalls for the tenth consecutive quarter, which reflects the increasing technological sophistication and complexities of modern medical devices as they become part of the expanding Internet of Things.
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About the Index
The Stericycle Recall Index aggregates and tracks recall data to help manufacturers and other industry stakeholders navigate the regulatory environment and identify trends. Each quarter Stericycle analyzes data from the U.S. Consumer Product Safety Commission (CPSC), the National Highway Traffic Safety Administration (NHTSA), the FDA, and the USDA.
To track trends in pharmaceutical and medical device recalls, the Stericycle Recall Index uses information publicly available in news releases posted on the FDA website. For additional insight into recalls governed by the FDA, Stericycle collects and analyzes data from the agency’s weekly enforcement reports, which provide additional details including recall class, quantity of units affected, and number of reported incidents.
In addition to pharmaceutical and medical device recalls, the company issues quarterly information on recalls in the food & beverage, automotive, and consumer product industries. The full Q3 2018 Recall Index is available for download.
(Source: Stericycle Expert Solutions)
