The U.S. House of Representatives’ oversight committee will hold a hearing today about an April 30 recall of children’s Tylenol and other medicines. In advance of that hearing, Alison Young of USA Today reports that the manufacturing place responsible for the medicine “was cited last year by regulators for ‘knowingly’ using a bacteria-tainted ingredient, according to a 2009 inspection report.”
The U.S. Food and Drug Administration also cited the McNeil Consumer Healthcare plant for a similar violation last month. The April inspection, which found serious manufacturing violations and drugs that were potentially too potent, prompted the current recall.
Young also reports that the FDA issued 43 warning letters since January 2009 to drug factories about poor practices that may have endangered patients.
Violations serious enough to prompt warning letters from the U.S. Food and Drug Administration include plants using equipment and ingredients contaminated with bacteria or insects, failing to do proper testing to ensure drug strength and purity, and ignoring consumer complaints that products were making them sick.
Among the cases Young cites are possible bacterial contamination of propofol, reports of bug parts in another company’s medicines and bacteria in calcium carbonate, which is used in antacids and a menopause drug.
That House hearing starts at 10 a.m. ET and will be webcast. To watch, click here.
NPR’s Scott Hensley has been staying on top of the recall story on the Shots blog.
(Hat tip to the Donald W. Reynolds Center for Business Journalism)