Local Company Admits Selling Tainted Children's Medications

By Kara Seymour

A Montgomery County healthcare company will pay $25 million after pleading guilty to selling children’s medications tainted with nickel and chromium, the U.S. Department of Justice announced Tuesday.

According to authorities, McNeil produced the tainted Infants’ Tylenol, Children’s Tylenol and Children’s Motrin at its facility in Fort Washington and failed to follow proper protocols after receiving consumer complaints.

In 2009, a consumer alerted the company that there were “black specks” in the liquid at the bottom of the bottle of Infants Tylenol, according to court documents. It was later determined to be nickel and chromium in the medication, which was not intended as ingredients.

After receiving the complaint, McNeil, a subsidiary of Johnson & Johnson, did not initiate or complete a Corrective Action Preventive Action plan in conformance with current Good Manufacturing Practices, the Department of Justice said in a statement.

A subsequent Food and Drug Administration investigation revealed metal particles were found in as many as 30 batches of children’s medications manufactured at the Fort Washington facility, according to information from the Department of Justice. The company did not follow protocols in those instances, either, the Department of Justice said.

In April 2010, McNeil announced a recall of certain unexpired infants’ and children’s drugs manufactured at the Fort Washington facility.

McNeil was charged with delivery for introduction into interstate commerce drugs that were deemed adulterated. As a result of the guilty plea, the company must pay a criminal fine of $20 million and forfeit $5 million.

“The law requires that drugs be produced under the most rigorous of quality standards. When companies fail to exercise the vigilance that the law demands, they will held be accountable” said First Assistant U.S. Attorney Louis D. Lappen. “Drug companies should be aware that failing to adhere to good manufacturing practices subjects them to penalties and prosecution.”

McNeil remains under a 2011 permanent injunction requiring it to make remedial measures before reopening its Fort Washington manufacturing facility.

“Drug quality – and especially with the medicines we give our children – is of paramount concern to the FDA. The FDA expects manufacturers to have systems in place that will quickly discover and correct problems with medical products before they enter the U.S. marketplace,” said Margaret A. Hamburg, M.D., Commissioner, U.S. Food and Drug Administration.

The case was investigated by the Food and Drug Administration Office of Criminal Investigations.