http://www.digitaljournal.com/life/health/usa-set-for-record-drug-recalls/article/397978

U.S. set for record drug recalls

Posted Aug 19, 2014 by Tim Sandle
According to a report from the Regulatory Affairs Professionals Society, the number of drug recalls in 2014 within the U.S. looks set to become the highest number of recalls to date.
U.S. Food and Drug Administration
U.S. Food and Drug Administration
fda
The report details that the most common type of medicines being recalled are those that fall under the Class II recall category. As defined by the U.S. Food and Drug Administration (FDA), a Class II Recall is "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."
The FDA has reported that there have been 836 recalls as of mid-August 2014, 650 of which are Class 2. In 2013 there were 1,225 recalls of which 84 percent were Class II. The increase in recalls has been steady in all Classes but Class II has seen the most significant growth. The 2012 statistics show that 76 percent of the 499 recalls were in Class II. If the rate continues along the current trajectory, then 2014 could surpass the record for the number of drug products withdrawn from the market.
The growth in these recall reports can be attributed mainly to compounding pharmacies. Many of those pharmacies had products which had possible — but unconfirmed — microbial contamination.
In 2012 Digital Journal was one of the first news outlets to break a major drugs contamination story. This centered on the recall of a steroid medication that was manufactured by the New England Compounding Center (NECC), and which was then distributed across the U.S. The drug, intended to be sterile, was contaminated with fungi. When injected there was a high risk of causing patient harm and, in some cases, due to meningitis. Since then various acts of legislation have been introduced to improve standards in relation to compounding pharmacies.