McNeil Consumer Healthcare, the Johnson & Johnson unit that recalled Children's Tylenol and other pediatric medicines, may face criminal charges or other serious actions from the Food and Drug Administration.

The federal agency is considering further penalties, charges, product seizures and other sanctions after a pattern  of quality control practices that led to the recall of more than 136 million bottles of Children's Tylenol, Motrin, Benadryl and Zyrtec. The medicines may have contained too much of the active ingredient, inactive ingredients, or metal specks.

McNeil has a history of other forms of contamination going back two years. Packages of Motrin were quietly removed from shelves in 2008 for suspected quality problems. The McNeil case has been referred to the office of criminal investigation within the FDA for possibly violating laws governing drug manufacturing and marketing.

McNeil denies any intent to deceive or hide anything and claims the risk of serious health problems resulting from the use of the recalled medicines was remote. The unit has replaced several senior executives in the wake of criticisms and plans to make system-wide improvements.

McNeil started receiving consumer complaints that a moldy smell came from their over-the-counter products and that some consumers were experiencing stomach problems in 2008. The unit says they tested the product for contamination and it came back negative. When consumer complaints subsided, they believed the issued has resolved itself.

In 2009, when complaints started again, McNeil recalled products starting in November and December of that year and then in January of this year. Last month, during a plant inspection, the FDA cited McNeil for failing to investigate 46 consumer complaints for foreign particles in products.

The day after receiving the report, McNeil issued the April 30 recall of children's medications.

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