In the pharmaceutical sector, drug recalls increased 11 percent to 102, the second highest quarter since Q3 2013, according to the Stericycle Recall Index which covers recalls in the food, pharmaceutical, automotive, medical device, and consumer product industries. Additionally, recalled units increased 641 percent to just over 52 million.
The main culprit was mislabeling, which was the top cause of recalls based on units (48.6 percent). In terms of individual pharmaceutical product recalls, failed specifications were the top reason at 22.5 percent, as it has been for the 10th consecutive quarter. Q4 also saw significantly more pharmaceutical companies impacted by recalls – 77 companies reported recalls in the quarter, making it the second highest since at least 2012. Medical device recalls decreased just one percent to 280 last quarter.
However, recalled units jumped 449 percent to just over 161 million – the second highest quarter since 2004. Machine failure was the top cause based on units (73.5 percent). But it was mainly due to one large recall. It was also the second consecutive quarter machine failure was the top cause based on units. For product recalls, software issues were the main cause for the eleventh consecutive quarter.
There were 79 software-related recalls, which far surpassed all other causes including mislabeling (43 recalls), quality issues (36 recalls), and sterility (27 recalls). Five companies reported 10 or more recalls in the quarter as well. This was the highest number of companies since Q3 2016 and the second highest since Q3 2013. The full Q4 2018 Recall Index is available here.
