FDA: JNJ Unit Failed To Test Tylenol For Contaminants

A Johnson & Johnson (JNJ) unit failed to test whether its pain reliever Tylenol was chemically contaminated despite receiving a heightened number of consumer complaints in 2008 that the pills smelled musty, according to a report by U.S. Food and Drug Administration inspectors.

In 2008, J&J's McNeil Consumer Healthcare received more than 70 musty odor complaints for Tylenol Arthritis Caplets. However, the company didn't conduct a formal investigation at the time even though more than eight of the complaints suggested the pills caused gastrointestinal problems in patients, the FDA report says.

The report says the company did physically examine whether the moldy odor originated from the presence of microorganisms and concluded it didn't.

McNeil spokeswoman Bonnie Jacobs said the company has received the FDA report and "is actively working in consultation with the FDA to address their concerns." She said the company wouldn't answer other questions at this time.

In early November McNeil said it was voluntarily recalling certain lots of Tylenol Arthritis Pain Caplet 100 count bottles after receiving consumer complaints that the product caused nausea and other symptoms. A month later the company expanded the recall to include all Tylenol Arthritis Caplet 100-count bottles, and said the odor was likely caused by chemically treated wood pallets being located near where the medicine is packaged.

FDA investigators inspected McNeil's Las Piedras, Puerto Rico plant from October 2009 through Jan. 8, 2010. After an inspection, FDA investigators present companies with report that details their findings. The report, posted to the FDA's Web site Wednesday, notes the company initiated the recall during the inspection.

The FDA says the company doesn't properly follow protocols for handling consumer plants. "For example, your firm received multiple uncharacteristic-smell consumer complaint reports since May 2008, but the trend was not detected until August 2008," according to the report.

The report also says the company didn't assess whether chemically treated wood pallets also caused moldy odor in its heartburn medicine Rolaids. The FDA said consumers have filed more than 10 complaints of moldy-smelling Rolaids.

-By Jared A. Favole, Dow Jones Newswires; 202.862.9207; jared.favole@dowjones.com