Pharmaceutical and medical device companies issued an unusually high number of recalls during the first quarter of 2018, according to the U.S. Recall Index compiled by Stericycle Expert Solutions.
Drug recalls jumped 52 percent to 105 – the highest number since the third quarter of 2013. Most – about 22 percent – were due to failed specifications, a cause that has been leading drug recalls for the seventh consecutive year.
Medical device recalls jumped 126 percent to 343 in the first quarter of 2018, more than doubling the number of recalls posted last quarter. It was the largest increase since 2005. Most medical device recalls – nearly 23 percent – were due to software issues. This was the eighth consecutive year software led medical device recalls.
Pharmaceutical and medical device companies issue recalls of products either by their own initiative, by the request of the Food and Drug Administration (FDA), or by FDA order under statutory authority, and are classified (I, II, III) according to the risk they pose to consumers. For example, a Class I recall involves situations where there is reasonable probability that use of or exposure to a violative product will cause serious adverse health consequences or death.
The Stericycle Recall Index aggregates and tracks recall data each quarter using information from the U.S. Consumer Product Safety Commission (CPSC), the National Highway Traffic Administration (NHTSA), the FDA and the USDA. Not only does the company compile recall data involving pharmaceutical and medical device recalls, it also issues quarterly reports about food & beverage, automotive and consumer product industry recalls.
FDA Drug Recalls
FDA Medical Devices