McNeil Warned for Not Alerting FDA to Contamination Sooner

January 25, 2010
The FDA has warned McNeil Consumer Healthcare for being too slow to alert the FDA and consumers to trace amounts of a wood-treating chemical in some of its products, including its OTC drug Tylenol. The company first received complaints of a musty and moldy smell in certain drug products in September 2008 but did not notify the FDA until a year later, so a warning letter has been issued, CDER Office of Compliance Director Deborah Autor said. McNeil expanded its recall of OTC products this month to include all lots that might be affected, the company said.
Washington Drug Letter