In the second quarter of 2018, pharmaceutical recalls dropped 27 percent to 77, which is lower than six of the last eight quarters, while recalled units dropped 95 percent to nearly 15.9 million, but in line with the recent average quarter (2013-2016), according to the latest U.S. Recall Index released August 8 by Stericycle Expert Solutions.
The Recall Index covers recalls in the pharmaceutical, medical device, and other select markets.
For the second quarter in a row, deviation from Current Good Manufacturing Practices (CGMP) was the top cause based on units recalled, while “failed specifications” was the top cause of recalls for the eighth quarter in a row.
Medical Device Sterility Struggles
Medical device recalls increased five percent to 360, making it the largest quarter since at least 2005 and surpassing last quarter’s record by 17 recalls. However, recalled units decreased 80 percent to about 42.4 million—lower than eight of the previous 13 quarters.
Sterility was the top cause for recalled units at 33.7 percent. This breaks a two-quarter run for manufacturing defects. The quarter also saw an increase in the number of companies experiencing multiple recalls. Sixteen companies reported at least five recalls in Q2, which is the largest since Q3 2013.
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 informaton on recalls in the food & beverage, automotive, and consumer product industries. The full Q2 2018 Recall Index is available for download.
(Source: Stericycle Expert Solutions)