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Wednesday, May 5, 2010

FDA Ties Tylenol Recall to Contamination

The Wall Street Journal

Raw materials that were to be used to make several lots of the Tylenol products for children and infants that were recalled over the weekend were contaminated, the Food and Drug Administration said Tuesday.

Johnson & Johnson recalled about 1,500 lots of bottled products, including pediatric versions of Tylenol, Motrin, Zyrtec and Benadryl. The company's McNeil Consumer Healthcare unit said it was withdrawing the over-the-counter products, starting late Friday, because of manufacturing problems at its Fort Washington, Pa., plant.

The FDA inspected the manufacturing plant during a routine visit between April 19 and April 30.

Agency inspectors found that raw materials set aside for use to make several lots were contaminated with gram-negative bacteria, according to the inspection report. Such organisms are so named because they don't pick up the purplish dye used in the test to distinguish them from gram-positive bacteria. Both kinds of bacteria can cause infections.

FDA officials said the company may have used the contaminated inactive ingredients in manufacturing, but the company's testing of finished products didn't turn up contamination.

"The findings are serious, but we cannot say yet whether further action by the FDA is warranted," Deborah Autor, the FDA's director of compliance, said in a conference call with reporters.

Some of the liquid products may contain a higher concentration of their active ingredient than they should, while others may contain inappropriate levels of inactive ingredients or tiny metallic particles left as a residue from the manufacturing process, according to the company. The FDA report cited 46 consumer complaints regarding "foreign materials, black or dark specks" that were reported to the company between June 2009 and April 2010.

A spokeswoman for J&J's McNeil unit said the company has halted production at one plant. Other plants also make the medicines, and there are lots from those plants that weren't recalled and remain on store shelves. The spokeswoman declined to comment on the cost of the recall to the company or the source of the raw materials.

In a separate statement, she said that the J&J unit's own reviews had turned up some of the quality issues that the FDA observed and that McNeil won't restart operations at the Fort Washington plant until it fixes the problems and can be assured of product quality.

"We have no higher concern than providing parents with the highest quality products for their children," the company's statement said.

FDA Commissioner Margaret Hamburg said the potential for harm is remote. Still, she urged parents to avoid giving the medicines for precautionary reasons. "There are many alternative versions of these medicines available in generic form," she said.

To assist parents, the company has set up a hot line at 888-222-6036 and a website at www.mcneilproductrecall.com.