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KRS Global Blog

Drug recalls could hit record high in 2014

If the number of drug recalls this year continues at its current rate, 2014 could bring in the highest number of recalls to date, according to a report from the Regulatory Affairs Professionals Society.
As of Aug. 11, pharmaceutical companies have initiated a total of 836 drug recalls. In 2013, there were 1,225 recalls, a significant jump from the 499 recalls in 2012.
The RAPS report finds the majority of recalls over the past handful of years were Class II, which the U.S. Food and Drug Administration categorizes as “a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.” In 2013, Class II recalls accounted for 84 percent of recalls. Already in 2014, 77 percent of recalls are classified as Class II.  
What’s causing the surge in Class II recalls? The RAPS report indicates the fungal meningitis outbreak of 2012 that was linked to a compounding pharmacy led to heightened scrutiny on such facilities by the FDA, and many Class II recalls since then were related to such compounding pharmacies. Additionally, the report suggests recalls initiated for current good manufacturing practice deficiencies can affect dozens of products at a time, each one requiring its own recall notice.
However, “not all recalls are created equal,” according to the report, which says a recall of thousands of drug products is treated the same as a recall for a single product. “Because many compounding pharmacy recalls are for just a small handful of products, it’s possible that even with a large surge in the number of recalls, the total amount of productrecalled could be relatively consistent.” (Original emphasis).