Recall activity for pharmaceutical products rose 35 percent in the second quarter of 2016 to their highest level since the third quarter of 2014, according to a new Recall Index report. It also found that medical device recall activity increased by 38 percent in the second quarter of 2016, making it a tie for highest quarter since the third quarter of 2014.
The report, published Tuesday by Stericycle ExpertSolutions, revealed trends in recalls across various sectors including pharmaceuticals and medical device.
Here are 10 other findings from the report.
Pharmaceuticals
- Seventy-nine percent of pharmaceutical recalls in the second quarter of 2016 were nationwide recalls.
- Fourteen companies experienced more than one pharmaceutical recall in the second quarter of 2016, the highest level in a quarter since the second quarter of 2015.
- The number of pharmaceutical units recalled in the second quarter of 2016 rose 169 percent compared to the previous quarter.
- Nearly 70 percent of recalled pharmaceutical units in the second quarter of 2016 were due to failed specifications.
- Sixty-six percent of recalled pharmaceutical units in the second quarter of 2016 were Class II, resuming a historical trend after a lower than average first quarter of 2016, when Class II accounted for 33 percent of recalled units.
Medical device
- The rate of recalled medical device units was three times higher in the second quarter of 2016, but was still 30 percent below the quarterly average in 2015.
- Nearly all (99 percent) of recalled medical device units in the second quarter of 2016 were considered Class II.
- Based on medical device recalls in the second quarter of 2016, the top three causes of these recalls were software, mislabeling and quality issues, making up a combined 51 percent of recalls.
- Nearly 90 percent of medical device recalled units in the second quarter of 2016 were recalled due to quality issues regarding specification and sterility concerns.
- Forty-nine percent of medical device unit recalls in the second quarter of 2016 were international, the lowest level since the fourth quarter of 2013.