The number of Food and Drug Administration recalls in the second quarter of 2014 — including drug and pharmaceuticals, medical devices and food — was the lowest it has been in the past two years. However, such recalls are growing in complexity, according to a Stericycle Recall Index report.
The Recall Index report found the 495 FDA recall events in Q2 2014 was actually 10 percent fewer than the previous quarter. Of those recall events, 91 were within the pharmaceutical sector, which has been the average number of quarterly pharmaceutical recalls since Q4 2012.
While the numbers have remained relatively stagnant, the number of companies and manufacturers contributing to recall events increased as did the geographic spread of the recalls.
The number of manufacturers involved in a recall — 71 — increased 18 percent from Q1 2014 to Q2 2014. Additionally, the majority of Q2 recalls — 86 percent — were nationwide, according to the report.
Approximately one-quarter of recalls affected at least one other country. The report indicates global recalls are a steadily growing trend. For example, only 12 percent of recalls in Q3 2013. International recalls add to the complexity of recall event response, as "manufacturers need the ability to not only quickly scale their response, but also ensure that all recall-related communications are translated to the respective languages — and, in some cases, alphabets — of the impacted regions," according to the report.
"It's evident that numerous trends converged within the pharmaceutical industry during the second quarter of the year to highlight the complexities of global recall execution," said Mike Rozembajgier, vice president of Stericycle. "These are just a few of the variables that underscore that even the most vigilant manufacturer will one day be faced with an event. As such, companies must ensure they are prepared to address all of the challenges of effective recall execution to minimize the fallout when a recall occurs."
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