Home » McNeil Warned for Not Alerting FDA to Contamination Sooner
McNeil Warned for Not Alerting FDA to Contamination Sooner
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
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