Recalls of both prescription and over-the-counter drugs soared in 2009, prompting questions about the quality of U.S. pharmaceutical manufacturing, CNN Money reports.
Last year, the Food and Drug Administration reported 1,742 recalls, up from 426 in 2008.
More than 1,000 of the recalls involved a single company, Advantage Dose, a now-defunct business that repackaged drugs. But even excluding the company, recalls still jumped about 50 percent.
And so far, 2010 also has been a brisk year for recalls. In the first half of the year, the FDA reported 296 recalls.
Experts say manufacturing problems such as the use of low- quality raw materials, contamination, and faulty labeling and packaging are contributing to the increase. Increased scrutiny by the FDA also may be a factor.
The agency would not provide any analysis of the surge. “We have not identified any trends,” a spokeswoman said.
The spike and some high-profile recalls, including a Johnson & Johnson unit’s recall of Tylenol and other well-known over-the-counter drugs, have highlighted quality control problems in drug manufacturing and drawn the attention of lawmakers. Congress has introduced two bills this year that would impose more stringent regulations on the pharmaceutical industry and give the FDA power to mandate recalls.
