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More Details Emerge on Children's Medicine Recall

May 19, 2010 | Parker Waichman LLP

The Wall Street Journal has published new details about McNeil Consumer Healthcare’s recent recall of over-the-counter children’s medicines. Much of what the Journal reports is disturbing.

On April 30, McNeil, a unit of Johnson & Johnson, recalled 43 varieties of Tylenol Infant Drops, Children’s Tylenol Suspensions, Children’s Tylenol Plus Suspensions, Motrin Infant Drops, Children’s Motrin Suspensions, Children’s Zyrtec Liquid in Bottles, and Children’s Benadryl Allergy Liquid in Bottles in the U.S. and 11 other countries. At the time, the company said some drugs might contain a higher concentration of active ingredient than is specified; others may contain inactive ingredients that may not meet internal testing requirements; and others may contain tiny particles.

The Wall Street Journal has obtained a copy of a letter McNeil sent to doctors and poison control centers on May 1 that provides more information about the recall. According to the letter, some samples of recalled infants’ Tylenol were found to contain as much as 24% more active ingredient than shown on the label.

McNeil maintained that none of the defective drugs had reached the marketplace. The letter also said that testing of other batches that had made it to market did not find any problems. But it also warned that the company couldn’t “confirm that all the individual bottles were within specification or that 24% would have been the maximum.”

The Wall Street Journal is also reporting that McNeil accidently neglected to one include variety of Children’s Zyrtec to the recall. It wasn’t until May 5 that it informed its sales staff via email that the 1 milligram grape version of children’s Zyrtec had not been included, and directed staff to alert customers immediately of the need to take the bottles off store shelves. The omission was attributed to a clerical error, the Journal said.

The U.S. Food & Drug Administration (FDA) is investigating manufacturing procedures at the Fort Washington, PA manufacturing facility where the recalled medicines were made. It is also investigating McNeil’s manufacturing company wide. In addition to the Fort Washington facility, McNeil makes drugs at plants in Lancaster, PA, and Las Piedras, Puerto Rico.

Since the April 30 recall, the Fort Washington plant has been closed until McNeil can assure quality production.

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