The US Food and Drug Administration's increased oversight of US drug manufacturing plants has led to a big jump in the number of drug products recalled in the third quarter of this year, according to a report issued by Stericycle ExpertRECALL, a company that tracks such trends. Specifically, the FDA recorded 150 recalls in the third quarter of 2011, up from 97 in the second quarter.
"The FDA has stepped up its oversight of US manufacturing plants and operations," Stericycle ExpertRECALL Vice President for Recalls Mike Rozembajgier wrote in an email to FiercePharma Manufacturing. "And with the US Government Accountability Office's recent call for the agency to intensify its efforts to track and regulate overseas pharmaceutical manufacturing, we can expect the FDA to intensify its oversight even more."
Very few (less than 7 percent) of the third-quarter recalls were made because the product in question had the potential to cause serious injury or death, but more than half were the result of possible adverse events that were serious enough to have irreversible consequences, according to the report.