FDA clocks record number of recalls
The FDA is setting a record. Regulatory Focus reports that the regulator has issued more recalls since the beginning of 2013 than it did over the previous nine years. RF says the record-breaking streak is punctuated by a spike in Class-II recalls, which means drugmakers pulled items which may cause “temporary or medically reversible adverse events.”
RF says Class-II recalls have become a mainstay of total recall numbers for a while, and that the uptick is linked to compounding pharmacies which have undergone increased scrutiny since the 2012 fungal meningitis outbreak that killed more than 60 patients.